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Study to Evaluate Immunogenicity of the Hepatitis B Antigen of the GSK Biologicals' Candidate Malaria Vaccine (257049)

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ClinicalTrials.gov Identifier: NCT01345240
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : February 10, 2014
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Malaria
Malaria Vaccines
Interventions Biological: GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Engerix-B™ vaccine
Biological: Infanrix/Hib™ vaccine
Biological: Polio Sabin™ vaccine
Biological: Rotarix™ vaccine
Biological: Synflorix™ vaccine
Biological: Measles vaccine
Biological: Yellow fever vaccine
Enrollment 705
Recruitment Details The study was conducted in 4 phases, a Primary Vaccination Phase (up to Month (M) 3), a Safety Follow-Up Phase (M3-8), a First Immunogenicity Follow-Up (FU) Phase (M8-26), and a Second Immunogenicity FU Phase (M26 to study end at M51).
Pre-assignment Details  
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Period Title: Overall Study
Started 142 142 141 141 139
Completed 131 128 123 132 129
Not Completed 11 14 18 9 10
Reason Not Completed
Adverse Event             3             5             4             2             1
Lost to Follow-up             8             9             14             7             9
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group Total
Hide Arm/Group Description This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Total of all reporting groups
Overall Number of Baseline Participants 142 142 141 141 139 705
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants 705 participants
8.4  (0.83) 8.3  (0.62) 8.3  (0.69) 8.3  (0.74) 8.3  (0.74) 8.32  (0.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants 705 participants
Female
59
  41.5%
69
  48.6%
67
  47.5%
81
  57.4%
63
  45.3%
339
  48.1%
Male
83
  58.5%
73
  51.4%
74
  52.5%
60
  42.6%
76
  54.7%
366
  51.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
African Heritage/African American Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants 705 participants
142
 100.0%
142
 100.0%
141
 100.0%
141
 100.0%
139
 100.0%
705
 100.0%
1.Primary Outcome
Title Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen
Hide Description A seroprotected subject was defined as a subject with anti-HBs antibody titers greater than or equal to (>=) the cut-off of 10 mili-international units per mililiter (mIU/mL). A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix -B).
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Group Engerix B Group
Hide Arm/Group Description:
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups who were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 397 253
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
100
(99.1 to 100)
96
(92.9 to 98.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RTS,S Group, Engerix B Group
Comments Non-inferiority of the immune response to the hepatitis B antigen induced by RTS,S/AS01E vaccine versus a licensed hepatitis B vaccine.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the difference in percent seroprotection below 5% between recipients of licensed hepatitis B vaccine (Engerix-B) and recipients of RTS,S/AS01E vaccine.
Method of Estimation Estimation Parameter Difference in percent seroprotection
Estimated Value -3.95
Confidence Interval (2-Sided) 95%
-7.12 to -2.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title Anti-Hepatitis B (HBs) Antibody Concentrations
Hide Description Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, with study groups pooled by primary vaccine administered (RTS,S vs Engerix-B).
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Group Engerix B Group
Hide Arm/Group Description:
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups who were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 397 253
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
6412.7
(5732.9 to 7173.0)
377.4
(310.6 to 458.7)
3.Primary Outcome
Title Anti-Hepatitis B (HBs) Antibody Concentrations.
Hide Description Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis, for each RTS,S Regimen A, B, C and each Engerix B Regimen A and B study groups.
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 140 123 134 135 118
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
5467.6
(4493.8 to 6652.5)
6989.9
(5747.5 to 8501.0)
6998.7
(5779.1 to 8475.7)
334.4
(253.4 to 441.4)
433.4
(329.5 to 570.1)
4.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Disorders (pIMDs)
Hide Description A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time Frame From Day 0 to Month 8.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Disorders (pIMDs)
Hide Description A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time Frame From Day 0 to Month 26
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time Frame From Day 0 to Month 8
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with SAE(s)
1
   0.7%
7
   4.9%
7
   5.0%
3
   2.1%
5
   3.6%
Subjects with fatal SAE(s)
1
   0.7%
2
   1.4%
2
   1.4%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time Frame From Day 0 to Month 26
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs - At Month 26
1
   0.7%
8
   5.6%
7
   5.0%
6
   4.3%
6
   4.3%
Fatal SAEs - At Month 26
1
   0.7%
3
   2.1%
2
   1.4%
2
   1.4%
1
   0.7%
8.Secondary Outcome
Title Anti-Hepatitis B (HBs) Antibody Concentrations
Hide Description Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for the study groups receiving the RTS,S vaccine, pooled by vaccine lot, that is, for the RTS,S Lot 1, RTS,S Lot 2, and RTS,S Lot 3 groups, as defined below.
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Lot 1 Group RTS,S Lot 2 Group RTS,S Lot 3 Group
Hide Arm/Group Description:
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 132 134 131
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
6214.3
(5115.6 to 7548.9)
6826.1
(5569.4 to 8366.3)
6209.2
(5144.2 to 7494.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RTS,S Lot 1 Group, RTS,S Lot 2 Group
Comments To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.
Type of Statistical Test Equivalence
Comments Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.69 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RTS,S Lot 1 Group, RTS,S Lot 3 Group
Comments To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.
Type of Statistical Test Equivalence
Comments Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
0.76 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RTS,S Lot 2 Group, RTS,S Lot 3 Group
Comments To demonstrate the lot-to-lot consistency in terms of anti-HBs immunogenicity between three commercial lots of the RTS,S/AS01E candidate malaria vaccine.
Type of Statistical Test Equivalence
Comments Criteria for consistency: one month post Dose 3 of RTS,S/AS01E, the two-sided 95% confidence interval (CI) of the geometric mean concentration (GMC) ratio between all pairs of lots are within [0.5, 2].
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.84 to 1.45
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Anti-Hepatitis B (HBs) Antibody Concentrations.
Hide Description Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Months 14 and 26, aka at 12 and 24 months post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 133 118 129 127 114
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs – At Month 14 Number Analyzed 133 participants 118 participants 129 participants 127 participants 114 participants
1530.1
(1259.4 to 1859.1)
2430.9
(1975.7 to 2991.0)
2189.1
(1840.3 to 2603.9)
119.5
(91.0 to 157.0)
137.5
(103.3 to 183.2)
Anti-HBs – At Month 26 Number Analyzed 132 participants 109 participants 124 participants 125 participants 110 participants
1092.6
(867.4 to 1376.3)
1896.0
(1487.2 to 2417.3)
1849.8
(1478.9 to 2313.6)
68.8
(50.7 to 93.3)
71.0
(51.6 to 97.8)
10.Secondary Outcome
Title Anti-Hepatitis B (HBs) Antibody Concentrations.
Hide Description Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 10 mIU/mL. A decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Results presented are for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Months 38, 50 and 51, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B and one month post the Month 50 booster dose of Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 131 111 122 127 106
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Month 38 Number Analyzed 128 participants 107 participants 120 participants 125 participants 105 participants
706.8
(548.0 to 911.6)
1081.7
(845.3 to 1384.2)
977.4
(786.7 to 1214.3)
39.0
(29.0 to 52.4)
41.2
(29.8 to 57.0)
Month 50 Number Analyzed 128 participants 111 participants 122 participants 127 participants 106 participants
499.4
(382.2 to 652.6)
765.3
(590.5 to 992.0)
807.3
(649.6 to 1003.4)
29.2
(22.0 to 38.7)
32.9
(23.9 to 45.4)
Month 51 Number Analyzed 131 participants 109 participants 122 participants 124 participants 105 participants
32345.9
(24758.5 to 42258.4)
54977.1
(43579.1 to 69356.4)
59630.0
(48606.1 to 73154.0)
8995.0
(5935.8 to 13631.0)
9578.9
(6374.2 to 14395.0)
11.Secondary Outcome
Title Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).
Hide Description Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 141 123 135 135 117
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
268.7
(226.8 to 318.3)
327.1
(272.2 to 393.1)
335.5
(283.2 to 397.5)
25.5
(22.8 to 28.7)
28.7
(24.6 to 33.4)
12.Secondary Outcome
Title Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1).
Hide Description Anti-HBs RF1 antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 33 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Month 51, aka one month post the Month 50 booster dose of Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 124 104 113 107 95
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
307.8
(239.0 to 396.4)
471.6
(372.5 to 597.1)
514.5
(415.3 to 637.5)
120.5
(86.6 to 167.6)
127.9
(94.5 to 173.1)
13.Secondary Outcome
Title Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations
Hide Description Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Month 3, aka at one month post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 141 123 136 135 118
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
142.2
(116.4 to 173.7)
188.5
(156.5 to 227.0)
205.5
(167.3 to 252.5)
NA [1] 
(NA to NA)
0.3
(0.3 to 0.4)
[1]
GMCs were not tabulated as they fell below the cut-off value for the assay.
14.Secondary Outcome
Title Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .
Hide Description Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 0.5 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups. No anti-CS results are available for the time point 24 months post Dose 3 (Month 26) because the quantity of serum available for the anti-CS assay was insufficient for many samples.
Time Frame At Month 14, aka at 12 months post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 91 82 96 85 76
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
5.7
(4.2 to 7.7)
6.8
(5.0 to 9.4)
7.5
(5.3 to 10.6)
0.3
(0.3 to 0.3)
0.3
(0.3 to 0.4)
15.Secondary Outcome
Title Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations .
Hide Description Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The assay cut-off was the seropositivity cut-off value of greater than or equal to (>=) 1.9 EL.U/mL. The table shows results for each RTS,S Regimen A, B & C, and for each Engerix B Regimen A & B study groups.
Time Frame At Months 38 and 50, aka 36 and 48 months post Dose 3 of RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 131 111 122 127 107
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Month 38 Number Analyzed 131 participants 107 participants 121 participants 126 participants 106 participants
2.6
(2.2 to 3.1)
2.8
(2.3 to 3.4)
3.5
(2.9 to 4.2)
1.0
(1.0 to 1.1)
1.0
(1.0 to 1.0)
Month 50 Number Analyzed 128 participants 111 participants 122 participants 127 participants 107 participants
2.3
(2.0 to 2.7)
2.4
(2.0 to 2.8)
2.7
(2.3 to 3.2)
1.1
(1.0 to 1.1)
1.1
(1.0 to 1.3)
16.Secondary Outcome
Title Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes.
Hide Description Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 µg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time Frame At Month 3, aka at one month post Dose 3 of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 141 135
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
ANTI-1 Number Analyzed 141 participants 135 participants
3.1
(2.8 to 3.6)
3.6
(3.1 to 4.2)
ANTI-4 Number Analyzed 141 participants 134 participants
3.5
(3.0 to 4.0)
4.2
(3.5 to 4.9)
ANTI-5 Number Analyzed 141 participants 135 participants
5.1
(4.5 to 5.8)
6.5
(5.6 to 7.4)
ANTI-6B Number Analyzed 141 participants 135 participants
1.1
(0.8 to 1.3)
1.2
(1.0 to 1.6)
ANTI-7F Number Analyzed 141 participants 135 participants
4.4
(3.9 to 4.9)
4.9
(4.3 to 5.7)
ANTI-9V Number Analyzed 141 participants 135 participants
2.8
(2.4 to 3.3)
3.7
(3.3 to 4.2)
ANTI-14 Number Analyzed 141 participants 134 participants
5.8
(5.0 to 6.7)
5.7
(4.7 to 7.0)
ANTI-18C Number Analyzed 141 participants 134 participants
3.4
(2.8 to 4.1)
6.2
(5.1 to 7.5)
ANTI-19F Number Analyzed 141 participants 134 participants
4.2
(3.4 to 5.2)
5.1
(4.1 to 6.4)
ANTI-23F Number Analyzed 141 participants 134 participants
1.3
(1.1 to 1.6)
1.5
(1.1 to 1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 1 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.95 to 1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 4 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.97 to 1.48
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 5 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
1.06 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 6B responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.83 to 1.65
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 7F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.94 to 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 9V responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
1.08 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 14 responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.77 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against 18C responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.38 to 2.38
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against serotype 19F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.21
Confidence Interval (2-Sided) 95%
0.89 to 1.65
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen A Group, Engerix B Regimen A Group
Comments To demonstrate the non-inferiority of antibody against 23F responses to the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of 10 pneumococcal serotypes titers (measured with an ELISA test), is below a limit of 2 for the pneumococcal conjugate vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.81 to 1.55
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes.
Hide Description Antibody concentrations were measured by GSK assay, and expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay, by GSK assay, was greater than or equal to (>=) 0.2 μg/mL. This corresponds to the standard ELISA value of 0.35 μg/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time Frame At Month 17, aka one month post the Month 16 booster dose of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 133 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
ANTI-1 Number Analyzed 133 participants 126 participants
4.5
(3.8 to 5.4)
5.4
(4.5 to 6.4)
ANTI-4 Number Analyzed 132 participants 125 participants
6.1
(5.1 to 7.2)
6.8
(5.7 to 8.0)
ANTI-5 Number Analyzed 133 participants 126 participants
6.5
(5.5 to 7.8)
7.6
(6.4 to 9.1)
ANTI-6B Number Analyzed 133 participants 126 participants
4.7
(4.0 to 5.5)
4.1
(3.5 to 4.9)
ANTI-7F Number Analyzed 133 participants 126 participants
7.1
(6.2 to 8.2)
7.2
(6.3 to 8.2)
ANTI-9V Number Analyzed 133 participants 126 participants
6.0
(5.1 to 7.1)
5.7
(4.9 to 6.6)
ANTI-14 Number Analyzed 133 participants 126 participants
9.0
(7.6 to 10.7)
9.0
(7.4 to 10.8)
ANTI-18C Number Analyzed 133 participants 126 participants
13.7
(11.5 to 16.3)
14.5
(12.3 to 17.2)
ANTI-19F Number Analyzed 133 participants 126 participants
6.0
(4.9 to 7.4)
7.2
(5.8 to 8.8)
ANTI-23F Number Analyzed 133 participants 126 participants
4.1
(3.4 to 5.1)
3.9
(3.2 to 4.8)
18.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes.
Hide Description The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time Frame At Month 3, aka at one month (1M) post Dose 3 of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 133 124
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
OPSONO-1 Number Analyzed 132 participants 124 participants
48.9
(34.6 to 68.9)
65.0
(45.0 to 93.7)
OPSONO-4 Number Analyzed 130 participants 123 participants
768.3
(617.6 to 955.8)
810.9
(676.5 to 972.0)
OPSONO-5 Number Analyzed 133 participants 124 participants
77.6
(61.9 to 97.3)
93.8
(73.6 to 119.6)
OPSONO-6B Number Analyzed 128 participants 121 participants
444.4
(295.0 to 669.5)
389.3
(250.1 to 606.1)
OPSONO-7F Number Analyzed 132 participants 124 participants
3774.0
(3232.7 to 4405.8)
3947.4
(3338.3 to 4667.7)
OPSONO-9V Number Analyzed 132 participants 122 participants
1257.7
(977.3 to 1618.7)
1469.3
(1180.4 to 1828.8)
OPSONO-14 Number Analyzed 132 participants 123 participants
1426.3
(1136.0 to 1790.9)
1269.0
(965.1 to 1668.6)
OPSONO-18C Number Analyzed 124 participants 118 participants
192.6
(139.2 to 266.4)
249.7
(185.0 to 337.0)
OPSONO-19F Number Analyzed 129 participants 123 participants
159.3
(109.9 to 231.0)
228.8
(160.4 to 326.3)
OPSONO-23F Number Analyzed 132 participants 121 participants
760.9
(476.3 to 1215.5)
735.6
(456.3 to 1185.9)
19.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes.
Hide Description The pneumococcal vaccine serotypes assessed were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Streptococcus pneumoniae opsonophagocytic activity was presented as the dilution of serum (opsonic titer) able to sustain 50 % killing of live pneumococci under the assay conditions, expressed as geometric mean titers (GMTs). The cut-off of the assay was an opsonic dilution >= 8. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix . Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time Frame At Month 17, aka one month post the Month 16 booster dose of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 130 121
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
OPSONO-1 Number Analyzed 130 participants 121 participants
649.9
(464.7 to 908.9)
840.1
(603.4 to 1169.7)
OPSONO-4 Number Analyzed 126 participants 116 participants
2347.1
(1847.4 to 2982.0)
2527.8
(2064.1 to 3095.7)
OPSONO-5 Number Analyzed 129 participants 121 participants
324.2
(244.1 to 430.5)
392.8
(291.3 to 529.6)
OPSONO-6B Number Analyzed 130 participants 116 participants
955.3
(761.4 to 1198.6)
828.2
(652.7 to 1050.9)
OPSONO-7F Number Analyzed 130 participants 118 participants
9167.3
(7979.2 to 10532.3)
7794.6
(6577.6 to 9236.8)
OPSONO-9V Number Analyzed 130 participants 118 participants
3035.3
(2523.3 to 3651.3)
3164.6
(2669.8 to 3751.1)
OPSONO-14 Number Analyzed 127 participants 119 participants
1975.7
(1565.8 to 2493.0)
1865.0
(1463.9 to 2375.9)
OPSONO-18C Number Analyzed 127 participants 115 participants
1694.1
(1188.6 to 2414.7)
1548.7
(1096.3 to 2188.0)
OPSONO-19F Number Analyzed 130 participants 121 participants
344.5
(223.0 to 532.3)
469.7
(320.0 to 689.4)
OPSONO-23F Number Analyzed 127 participants 118 participants
3199.8
(2543.7 to 4025.1)
3198.1
(2526.5 to 4048.4)
20.Secondary Outcome
Title Anti-protein D (PD) Antibody Concentrations
Hide Description Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix-B Regimen A groups.
Time Frame At Month 3, aka at one month post Dose 3 of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 141 134
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
2435.3
(2204.3 to 2690.6)
2956.7
(2647.5 to 3302.1)
21.Secondary Outcome
Title Anti-protein D (PD) Antibody Concentrations
Hide Description Anti-PD antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to 100 EL.U/mL. This outcome concerns the subjects who received the RTS,S or Engerix -B vaccine co-administered with Synflorix. Results presented are for the study groups pooled by co-administration, that is, for the RTS,S Regimen A and Engerix -B Regimen A groups.
Time Frame At Month 17, aka one month post the Month 16 booster dose of Synflorix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen A Group Engerix B Regimen A Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 133 126
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
2648.3
(2194.2 to 3196.4)
2819.1
(2391.1 to 3323.7)
22.Secondary Outcome
Title Concentrations of Antibodies Against Acellular B-pertussis (BPT)
Hide Description The antibodies against BPT assessed were against pertussis toxoid (anti-PT), against filamentous haemagglutinin (anti-FHA), and against pertactin (anti-PRN). Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off value of greater than or equal to (>=) 5 EL.U/mL. The table shows results for study groups pooled by primary vaccine administered (RTS,S vs Engerix -B)
Time Frame At Day 0 and at Month 3 (one month post Dose 3 of Infanrix-Hib)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Group Engerix B Group
Hide Arm/Group Description:
Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix, Engerix B and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix-Hib, Polio Sabin, Rotarix, Synflorix, Rotarix and of vaccines against yellow fever and against measles. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 401 253
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT – At Day 0 Number Analyzed 401 participants 253 participants
3.8
(3.6 to 4.1)
4.3
(3.9 to 4.8)
Anti-PT – At Month 3 Number Analyzed 387 participants 247 participants
105.9
(99.2 to 113.1)
114.2
(104.8 to 124.5)
Anti-FHA – At Day 0 Number Analyzed 399 participants 253 participants
13.9
(12.7 to 15.2)
15.7
(14.1 to 17.5)
Anti-FHA – At Month 3 Number Analyzed 386 participants 247 participants
271.1
(252.8 to 290.8)
292.9
(268.9 to 319.1)
Anti-PRN – At Day 0 Number Analyzed 401 participants 253 participants
3.2
(3.0 to 3.4)
3.2
(3.0 to 3.5)
Anti-PRN – At Month 3 Number Analyzed 387 participants 247 participants
164.1
(153.6 to 175.3)
179.7
(164.4 to 196.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RTS,S Group, Engerix B Group
Comments To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertussis toxoid, (PT) of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.97 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RTS,S Group, Engerix B Group
Comments To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, filamentous haemagglutinin (FHA), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.97 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RTS,S Group, Engerix B Group
Comments To demonstrate the non-inferiority of antibody response to the acellular B pertussis antigen, pertactin (anti-PRN), of the DTPa/Hib vaccine when co-administered with RTS,S/AS01E as part of an EPI regimen.
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 3, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the GMC ratios of anti-PT, anti-FHA, anti-PRN antibody concentrations, is below a limit of 2 for the DTPa/Hib vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.98 to 1.22
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Anti-Rotavirus (Anti-RV) Antibody Concentrations
Hide Description Anti-Rotavirus (anti-RV) antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs). The cut-off of the assay was the seropositive cut-off value of greater than or equal to (>=) 20 units per milliliter (U/mL). This outcome measure was assessed in subjects who were administered Rotarix as part of an EPI regimen, with and without RTS,S vaccine co-administration. This outcome concerns the subjects who received the RTS,S or Engerix-B vaccine co-administered with Rotarix. Results presented are for the study groups pooled by RTS,S or Engerix-B vaccine co-administration, that is, for the RTS,S Regimen B and Engerix-B Regimen B groups.
Time Frame At Month 3, aka one month post Dose 2 of Rotarix
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity measures were available.
Arm/Group Title RTS,S Regimen B Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 120 116
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
24.9
(19.3 to 32.0)
27.6
(20.8 to 36.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RTS,S Regimen B Group, Engerix B Regimen B Group
Comments To demonstrate the non-inferiority of antibody response to the rotavirus vaccine when co-administered with versus without RTS,S/AS01E as part of an EPI regimen
Type of Statistical Test Non-Inferiority
Comments Criteria for non-inferiority: one month post Dose 2, upper limit (UL) of the 2-sided 95% confidence interval (CI) on the geometric mean concentrations (GMC) ratios of rotavirus antibodies (IgA) concentrations is below 2 for the rotavirus vaccine when co-administered with versus without RTS,S/AS01E.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.76 to 1.61
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling at the site of injection. All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination. Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited local symptoms, that is, the occurrences of these symptoms regardless of their intensity grade.
Time Frame Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Pain - Post D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
41
  28.9%
28
  19.7%
31
  22.0%
29
  20.6%
15
  10.8%
Pain – Post D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
30
  21.3%
14
  11.1%
21
  14.9%
24
  17.0%
9
   7.3%
Pain – Post D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
14
   9.9%
10
   7.9%
14
   9.9%
18
  12.8%
7
   5.7%
Redness – Post D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
1
   0.7%
0
   0.0%
2
   1.4%
5
   3.5%
1
   0.7%
Redness – Post D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
5
   3.5%
1
   0.8%
2
   1.4%
3
   2.1%
0
   0.0%
Redness – Post D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
3
   2.1%
0
   0.0%
1
   0.7%
3
   2.1%
0
   0.0%
Swelling – Post D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
5
   3.5%
2
   1.4%
6
   4.3%
10
   7.1%
4
   2.9%
Swelling – Post D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
8
   5.7%
3
   2.4%
4
   2.8%
9
   6.4%
4
   3.3%
Swelling – Post D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
7
   5.0%
2
   1.6%
6
   4.3%
11
   7.8%
3
   2.4%
25.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fever, irritability/fussiness, drowsiness, and loss of appetite. Fever was defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C). Analysis for this outcome was performed solely for the 7-days follow-up periods following the primary vaccination with RTS,S vaccine or Engerix-B (at Day 0, and Months 1 and 2). Data presented are those for any occurrence of the assessed solicited general symptoms, that is, the occurrences of these symptoms regardless of their intensity grade or relationship to vaccination.
Time Frame Within the 7-day follow-up period (Days 0-6) after administration of Dose (D) 1, 2 and 3, respectively, with RTS,S or Engerix-B vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had their symptom sheets filled-in.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Fever – D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
44
  31.0%
20
  14.1%
16
  11.3%
23
  16.3%
13
   9.4%
Fever – D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
30
  21.3%
14
  11.1%
18
  12.8%
20
  14.2%
5
   4.1%
Fever – D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
38
  27.0%
20
  15.9%
26
  18.4%
16
  11.3%
12
   9.8%
Irritability – D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
15
  10.6%
11
   7.7%
11
   7.8%
9
   6.4%
5
   3.6%
Irritability – D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
13
   9.2%
7
   5.6%
12
   8.5%
10
   7.1%
0
   0.0%
Irritability – D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
5
   3.5%
3
   2.4%
10
   7.1%
6
   4.3%
1
   0.8%
Drowsiness – D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
2
   1.4%
1
   0.7%
3
   2.1%
3
   2.1%
0
   0.0%
Drowsiness – D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
5
   3.5%
1
   0.8%
1
   0.7%
3
   2.1%
0
   0.0%
Drowsiness – D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
3
   2.1%
0
   0.0%
2
   1.4%
1
   0.7%
0
   0.0%
Loss of appetite – D1 Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
4
   2.8%
1
   0.7%
2
   1.4%
4
   2.8%
0
   0.0%
Loss of appetite – D2 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
3
   2.1%
1
   0.8%
1
   0.7%
3
   2.1%
0
   0.0%
Loss of appetite – D3 Number Analyzed 141 participants 126 participants 141 participants 141 participants 123 participants
2
   1.4%
0
   0.0%
1
   0.7%
1
   0.7%
1
   0.8%
26.Secondary Outcome
Title Number of Subjects With Potential Immune Mediated Disorders (pIMDs)
Hide Description A potential immune mediated disorder (pIMD) was defined as an event about which concerns arose that vaccination may have interfered with immunological self-tolerance of the subjects. IMDs assessed included among others neuroinflammatory disorders (such as optic neuritis, multiple sclerosis, or encephalitis), musculoskeletal disorders (such as cutaneous lupus, rheumatoid arthritis, juvenile arthritis, or psoriatic arthropathy), gastrointestinal disorders (ulcerative colitis and ulcerative proctitis, celiac disease), metabolic diseases (such as autoimmune thyroiditis, or diabetes Mellitus Type 1, Addison’s disease), skin disorders (such as psoriasis or vitiligo), and other disorders such as vasculitis, pernicious anemia, or, sarcoidosis.
Time Frame From Day 0 up to Study End (Month 51)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
121
  85.2%
115
  81.0%
120
  85.1%
120
  85.1%
105
  75.5%
28.Secondary Outcome
Title Number of Subjects With Any and Fatal Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject.
Time Frame Within the 30-day follow-up periods (Days 0-29) after vaccination with RTS,S vaccine or Engerix-B
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Subject with SAE(s)
1
   0.7%
3
   2.1%
3
   2.1%
1
   0.7%
3
   2.2%
Subjects with fatal SAE(s)
1
   0.7%
0
   0.0%
1
   0.7%
0
   0.0%
0
   0.0%
29.Secondary Outcome
Title Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs)
Hide Description A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or a reported adverse event of specific interest such as seizures occurring within a 30-day period of vaccination, immune-mediated disorders, and specific autoimmune diseases. A fatal SAE was defined as a SAE resulting in the death of the study subject. A related SAE was defined as a SAE assessed by the investigator as being causally related to vaccination.
Time Frame From Day 0 up to Study End (Month 51)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description:
This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
Overall Number of Participants Analyzed 142 142 141 141 139
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAEs Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
3
   2.1%
10
   7.0%
9
   6.4%
6
   4.3%
6
   4.3%
Fatal SAEs Number Analyzed 142 participants 142 participants 141 participants 141 participants 139 participants
3
   2.1%
5
   3.5%
4
   2.8%
2
   1.4%
1
   0.7%
Related SAEs Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
Time Frame Solicited local, general symptoms and unsolicited AEs: within the 30-day periods after primary co-administration vaccination. SAEs: during the entire study period (Month 0 to Month 51).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Hide Arm/Group Description This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib, Polio Sabin and Synflorix, at Weeks 0, 4 and 8, and 2 doses of Rotarix vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix, at Weeks 6 and 10, and 3 doses of Synflorix at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. The RTS,S vaccine and Engerix B were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib, Polio Sabin and Synflorix at Weeks 0, 4 and 8, and 2 doses of Rotarix, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid. Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B co-administered with Infanrix-Hib and Polio Sabin, at Weeks 0, 4 and 8, 2 doses of Rotarix vaccine, at Weeks 4 and 8, and 3 doses of Synflorix at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix-Hib and Synflorix, at Month 16, and one booster dose of Engerix B vaccine, at Month 50. Engerix B was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix-Hib IM in the right deltoid, Synflorix IM in the right anterolateral thigh, and Rotarix and Polio Sabin orally. The measles and yellow fever vaccines were administered IM in the deltoid.
All-Cause Mortality
RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/142 (2.11%)      5/142 (3.52%)      4/141 (2.84%)      2/141 (1.42%)      1/139 (0.72%)    
Show Serious Adverse Events Hide Serious Adverse Events
RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/142 (2.11%)      10/142 (7.04%)      9/141 (6.38%)      6/141 (4.26%)      6/139 (4.32%)    
Blood and lymphatic system disorders           
Anaemia † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 1/141 (0.71%)  1 3/141 (2.13%)  3 2/139 (1.44%)  2
Intravascular haemolysis † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Cardiac disorders           
Cardiac failure congestive † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Congenital, familial and genetic disorders           
Glucose-6-phosphate dehydrogenase deficiency † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Hypertrophic cardiomyopathy † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Gastrointestinal disorders           
Gastrointestinal haemorrhage † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
General disorders           
Pyrexia † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Infections and infestations           
Bacterial sepsis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Bronchiolitis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Bronchitis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 0/141 (0.00%)  0 1/139 (0.72%)  1
Endocarditis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Escherichia urinary tract infection † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Fungal infection † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Gastroenteritis † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 2/141 (1.42%)  2 0/141 (0.00%)  0 1/139 (0.72%)  1
Malaria † 1  1/142 (0.70%)  1 2/142 (1.41%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2 1/139 (0.72%)  1
Meningitis bacterial † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Meningitis streptococcal † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Pharyngitis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Pneumonia † 1  1/142 (0.70%)  1 2/142 (1.41%)  2 2/141 (1.42%)  2 2/141 (1.42%)  2 1/139 (0.72%)  1
Salmonella sepsis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Sepsis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1 0/139 (0.00%)  0
Trichomoniasis intestinal † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Injury, poisoning and procedural complications           
Accident † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Metabolism and nutrition disorders           
Failure to thrive † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Malnutrition † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Nervous system disorders           
Febrile convulsion † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1 1/139 (0.72%)  1
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RTS,S Regimen A Group RTS,S Regimen B Group RTS,S Regimen C Group Engerix B Regimen A Group Engerix B Regimen B Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   135/142 (95.07%)      129/142 (90.85%)      132/141 (93.62%)      135/141 (95.74%)      119/139 (85.61%)    
Blood and lymphatic system disorders           
Anaemia † 1  1/142 (0.70%)  2 0/142 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2 2/139 (1.44%)  2
Iron deficiency anaemia † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Congenital, familial and genetic disorders           
Respiratory tract malformation † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Ear and labyrinth disorders           
Excessive cerumen production † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1 0/139 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2 2/139 (1.44%)  2
Anal fissure † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 2/141 (1.42%)  2 1/139 (0.72%)  1
Diarrhoea † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 1/141 (0.71%)  1 2/141 (1.42%)  2 0/139 (0.00%)  0
Enteritis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Gastrooesophageal reflux disease † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Mouth ulceration † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Stomatitis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
General disorders           
Pain † 1  55/142 (38.73%)  85 40/142 (28.17%)  52 47/141 (33.33%)  66 48/141 (34.04%)  71 25/139 (17.99%)  32
Pyrexia † 1  81/142 (57.04%)  116 49/142 (34.51%)  56 50/141 (35.46%)  66 55/141 (39.01%)  65 34/139 (24.46%)  37
Swelling † 1  17/142 (11.97%)  20 7/142 (4.93%)  7 14/141 (9.93%)  16 23/141 (16.31%)  30 10/139 (7.19%)  11
Immune system disorders           
Drug hypersensitivity † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 2/139 (1.44%)  2
Infections and infestations           
Abscess † 1  2/142 (1.41%)  2 0/142 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2 0/139 (0.00%)  0
Acarodermatitis † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Anal fungal infection † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Bronchiolitis † 1  8/142 (5.63%)  9 5/142 (3.52%)  5 5/141 (3.55%)  5 4/141 (2.84%)  4 4/139 (2.88%)  4
Bronchitis † 1  36/142 (25.35%)  47 33/142 (23.24%)  35 28/141 (19.86%)  35 28/141 (19.86%)  31 29/139 (20.86%)  37
Bullous impetigo † 1  3/142 (2.11%)  3 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Candida infection † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2 0/139 (0.00%)  0
Conjunctivitis † 1  8/142 (5.63%)  8 10/142 (7.04%)  10 11/141 (7.80%)  12 9/141 (6.38%)  10 7/139 (5.04%)  7
Conjunctivitis bacterial † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 1/141 (0.71%)  1 2/141 (1.42%)  2 0/139 (0.00%)  0
Dysentery † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  2 0/139 (0.00%)  0
Ear infection † 1  2/142 (1.41%)  2 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Folliculitis † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Fungal infection † 1  3/142 (2.11%)  3 3/142 (2.11%)  3 5/141 (3.55%)  5 3/141 (2.13%)  3 4/139 (2.88%)  4
Fungal skin infection † 1  1/142 (0.70%)  1 7/142 (4.93%)  7 6/141 (4.26%)  6 12/141 (8.51%)  12 4/139 (2.88%)  4
Furuncle † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 2/141 (1.42%)  2 2/139 (1.44%)  2
Gastroenteritis † 1  42/142 (29.58%)  55 47/142 (33.10%)  58 51/141 (36.17%)  71 43/141 (30.50%)  57 38/139 (27.34%)  47
Gastrointestinal candidiasis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 1/141 (0.71%)  1 0/139 (0.00%)  0
Impetigo † 1  3/142 (2.11%)  3 1/142 (0.70%)  1 0/141 (0.00%)  0 2/141 (1.42%)  2 4/139 (2.88%)  4
Laryngitis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Malaria † 1  44/142 (30.99%)  50 44/142 (30.99%)  54 39/141 (27.66%)  46 49/141 (34.75%)  52 44/139 (31.65%)  53
Nasopharyngitis † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 2/141 (1.42%)  2 0/141 (0.00%)  0 3/139 (2.16%)  3
Oral candidiasis † 1  5/142 (3.52%)  5 3/142 (2.11%)  3 3/141 (2.13%)  3 4/141 (2.84%)  4 1/139 (0.72%)  1
Oral herpes † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Otitis externa † 1  4/142 (2.82%)  4 3/142 (2.11%)  3 1/141 (0.71%)  1 1/141 (0.71%)  1 0/139 (0.00%)  0
Otitis media † 1  11/142 (7.75%)  11 12/142 (8.45%)  13 6/141 (4.26%)  6 15/141 (10.64%)  19 10/139 (7.19%)  11
Otitis media acute † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Parasitic gastroenteritis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Pharyngitis † 1  23/142 (16.20%)  24 13/142 (9.15%)  15 15/141 (10.64%)  19 15/141 (10.64%)  18 17/139 (12.23%)  18
Pneumonia † 1  5/142 (3.52%)  5 14/142 (9.86%)  15 4/141 (2.84%)  4 11/141 (7.80%)  11 2/139 (1.44%)  2
Pyoderma † 1  5/142 (3.52%)  7 7/142 (4.93%)  7 5/141 (3.55%)  5 6/141 (4.26%)  7 3/139 (2.16%)  3
Rash pustular † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Respiratory tract infection † 1  10/142 (7.04%)  10 14/142 (9.86%)  16 15/141 (10.64%)  18 12/141 (8.51%)  13 10/139 (7.19%)  11
Rhinitis † 1  32/142 (22.54%)  37 35/142 (24.65%)  41 33/141 (23.40%)  41 31/141 (21.99%)  36 31/139 (22.30%)  36
Skin bacterial infection † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1 0/139 (0.00%)  0
Staphylococcal infection † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Staphylococcal skin infection † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Tinea infection † 1  0/142 (0.00%)  0 2/142 (1.41%)  2 2/141 (1.42%)  2 1/141 (0.71%)  1 0/139 (0.00%)  0
Upper respiratory tract infection † 1  16/142 (11.27%)  18 8/142 (5.63%)  9 12/141 (8.51%)  15 8/141 (5.67%)  9 7/139 (5.04%)  10
Urinary tract infection † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 3/141 (2.13%)  3 1/141 (0.71%)  1 0/139 (0.00%)  0
Viral infection † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 0/141 (0.00%)  0 1/141 (0.71%)  1 1/139 (0.72%)  1
Viral upper respiratory tract infection † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 1/141 (0.71%)  1 0/141 (0.00%)  0 1/139 (0.72%)  1
Visceral larva migrans † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Wound infection † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Injury, poisoning and procedural complications           
Arthropod bite † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Contusion † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Foreign body in eye † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Wound † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 1/139 (0.72%)  1
Metabolism and nutrition disorders           
Decreased appetite † 1  7/142 (4.93%)  9 2/142 (1.41%)  2 4/141 (2.84%)  4 5/141 (3.55%)  8 1/139 (0.72%)  1
Musculoskeletal and connective tissue disorders           
Arthritis † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 0/141 (0.00%)  0 1/139 (0.72%)  1
Nervous system disorders           
Somnolence † 1  8/142 (5.63%)  10 2/142 (1.41%)  2 5/141 (3.55%)  6 5/141 (3.55%)  7 0/139 (0.00%)  0
Psychiatric disorders           
Irritability † 1  28/142 (19.72%)  33 18/142 (12.68%)  21 27/141 (19.15%)  33 19/141 (13.48%)  25 5/139 (3.60%)  6
Renal and urinary disorders           
Dysuria † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 0/141 (0.00%)  0 0/141 (0.00%)  0 0/139 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Allergic bronchitis † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Cough † 1  0/142 (0.00%)  0 2/142 (1.41%)  2 2/141 (1.42%)  2 0/141 (0.00%)  0 0/139 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis † 1  0/142 (0.00%)  0 1/142 (0.70%)  1 1/141 (0.71%)  1 1/141 (0.71%)  1 1/139 (0.72%)  1
Dermatitis allergic † 1  0/142 (0.00%)  0 0/142 (0.00%)  0 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Dermatitis atopic † 1  0/142 (0.00%)  0 3/142 (2.11%)  3 0/141 (0.00%)  0 1/141 (0.71%)  1 0/139 (0.00%)  0
Dermatitis diaper † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 0/141 (0.00%)  0 2/141 (1.42%)  2 1/139 (0.72%)  1
Dermatosis † 1  1/142 (0.70%)  1 1/142 (0.70%)  1 3/141 (2.13%)  3 4/141 (2.84%)  4 1/139 (0.72%)  1
Eczema † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 1/141 (0.71%)  1 0/141 (0.00%)  0 0/139 (0.00%)  0
Erythema † 1  19/142 (13.38%)  19 8/142 (5.63%)  8 20/141 (14.18%)  20 12/141 (8.51%)  13 6/139 (4.32%)  6
Prurigo † 1  1/142 (0.70%)  1 0/142 (0.00%)  0 4/141 (2.84%)  4 0/141 (0.00%)  0 1/139 (0.72%)  1
1
Term from vocabulary, MedDRA
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
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