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

• ClinicalTrials.gov Identifier: NCT01345240
• Recruitment Status: Completed
• First Posted: May 2, 2011
• Results First Posted: February 10, 2014
• Last Update Posted: July 18, 2019
• Sponsor: GlaxoSmithKline
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage of Seroprotected Subjects Against Anti-Hepatitis B (HBs) Antigen
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

Outcome Measure Data

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
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)

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 for RTS,S Group and Engerix B Group
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

Outcome Measure Data

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
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 for All Study Groups
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

Outcome Measure Data

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
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	Anti-Hepatitis B (HBs) Antibody Concentrations at Month 3
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

Outcome Measure Data

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
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)

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]

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]

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]

5. Secondary Outcome

Title	Anti-Hepatitis B (HBs) Antibody Concentrations at Month 14 and 26
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

Outcome Measure Data

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
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)

6. Secondary Outcome

Title	Anti-Hepatitis B (HBs) Antibody Concentrations at Month 38, 50 and 51
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

Outcome Measure Data

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
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)

7. Secondary Outcome

Title	Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 3
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

Outcome Measure Data

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
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)

8. Secondary Outcome

Title	Concentrations of Antibodies to the Hepatitis B RF1 Surface Antigen (Anti-HBs RF1) at Month 51
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

Outcome Measure Data

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
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)

9. Secondary Outcome

Title	Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 3
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

Outcome Measure Data

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
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)	0.3; (0.3 to 0.3)	0.3; (0.3 to 0.4)

10. Secondary Outcome

Title	Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 14
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

Outcome Measure Data

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
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)

11. Secondary Outcome

Title	Anti-circumsporozoite Protein (Anti-CS) Antibody Concentrations at Month 38 and 50
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

Outcome Measure Data

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
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)

12. Secondary Outcome

Title	Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 3
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

Outcome Measure Data

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
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	140 participants	134 participants
		1.3; (1.1 to 1.6)	1.5; (1.1 to 1.9)

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

13. Secondary Outcome

Title	Pneumococcal Antibody Concentrations Against Synflorix Pneumococcal Vaccine Serotypes at Month 17
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

Outcome Measure Data

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
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)

14. Secondary Outcome

Title	Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 3
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

Outcome Measure Data

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
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)

15. Secondary Outcome

Title	Titers for Opsonophagocytic Activity Against Synflorix Pneumococcal Vaccine Serotypes at Month 17
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

Outcome Measure Data

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
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)

16. Secondary Outcome

Title	Anti-protein D (PD) Antibody Concentrations at Month 3
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

Outcome Measure Data

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
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)

17. Secondary Outcome

Title	Anti-protein D (PD) Antibody Concentrations at Month 17
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

Outcome Measure Data

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
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)

18. Secondary Outcome

Title	Concentrations of Antibodies Against Acellular B-pertussis (BPT) at Day 0 and at Month 3
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)

Outcome Measure Data

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
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)

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]

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]

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]

19. Secondary Outcome

Title	Anti-Rotavirus (Anti-RV) Antibody Concentrations
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

Outcome Measure Data

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
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)

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]

20. Secondary Outcome

Title	Number of Subjects With Solicited Local Symptoms
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

Outcome Measure Data

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
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%

21. Secondary Outcome

Title	Number of Subjects With Solicited General Symptoms
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

Outcome Measure Data

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
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%

22. Secondary Outcome

Title	Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 8
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

Outcome Measure Data

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
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%

23. Secondary Outcome

Title	Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 to Month 26
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

Outcome Measure Data

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
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%

24. Secondary Outcome

Title	Number of Subjects With Potential Immune Mediated Disorders (pIMDs) From Day 0 up to Study End (Month 51)
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)

Outcome Measure Data

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
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%

25. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
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

Outcome Measure Data

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
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%

26. Secondary Outcome

Title	Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) Within the 30-day Follow-up Periods (Days 0-29)
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

Outcome Measure Data

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
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%

27. Secondary Outcome

Title	Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 8
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

Outcome Measure Data

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
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%

28. Secondary Outcome

Title	Number of Subjects With Any and Fatal Serious Adverse Events (SAEs) From Day 0 to Month 26
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

Outcome Measure Data

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
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%

29. Secondary Outcome

Title	Number of Subjects With Any, Fatal and Related Serious Adverse Events (SAEs) From Day 0 up to Study End (Month 51)
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)

Outcome Measure Data

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
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

Adverse Events

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
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%)
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
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

Limitations and Caveats

[Not Specified]

More Information

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
• Phone: 866-435-7343

Publications:

Valéa I, Adjei S, Usuf E, Traore O, Ansong D, Tinto H, Owusu Boateng H, Leach A, Mwinessobaonfou Some A, Buabeng P, Vekemans J, Nana LA, Kotey A, Vandoolaeghe P, Ouedraogo F, Sambian D, Lievens M, Tahita MC, Rettig T, Jongert E, Lompo P, Idriss A, Borys D, Ouedraogo S, Prempeh F, Habib MA, Schuerman L, Sorgho H, Agbenyega T. Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial. Hum Vaccin Immunother. 2018 Jun 3;14(6):1489-1500. doi: 10.1080/21645515.2018.1442996. Epub 2018 Apr 13.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01345240
• Other Study ID Numbers: 113681; 2011-001508-37 ( EudraCT Number )
• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Results First Submitted: December 19, 2013
• Results First Posted: February 10, 2014
• Last Update Posted: July 18, 2019