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Trial record 6 of 68 for:    Diseases | ( Map: Mozambique )

Long-Term Follow-up of Children for a 2-Year Period to Confirm the Safety and Immunogenicity of GSK 257049 Vaccine

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ClinicalTrials.gov Identifier: NCT00323622
Recruitment Status : Completed
First Posted : May 9, 2006
Results First Posted : March 27, 2014
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Biological: Engerix™-B
Biological: Hiberix®
Biological: Prevnar™
Drug: sulfadoxine-pyrimethamine
Drug: amodiaquine
Enrollment 1737
Recruitment Details This current study NCT00323622, a follow-up (FU) study to the primary study NCT00197041, is aimed at vaccine safety assessment, and took place from Months 21 to 45 (Month 0 = Dose 1 administration of RTS,S/AS02A (GSK 257049) or comparator vaccine in the primary study).
Pre-assignment Details Once re-enrolled, subjects in this study were allocated to the same groups as in the NCT00197041 study, as well as the same cohorts, e. a. Cohorts 1 and 2 whose subjects were followed for analysis of, respectively, malaria infection and disease.
Arm/Group Title Cohort 1-RTS,S/AS02A<24M Group Cohort 1-RTS,S/AS02A≥24M Group Cohort 2-RTS,S/AS02A<24M Group Cohort 2-RTS,S/AS02A≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Hide Arm/Group Description Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
Period Title: Overall Study
Started 176 515 42 134 159 528 43 140
Completed 145 423 38 122 120 454 38 125
Not Completed 31 92 4 12 39 74 5 15
Reason Not Completed
Other             30             91             4             12             32             74             5             13
Death             1             1             0             0             7             0             0             2
Arm/Group Title Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group Total
Hide Arm/Group Description Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Total of all reporting groups
Overall Number of Baseline Participants 176 515 42 134 159 528 43 140 1737
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 176 participants 515 participants 42 participants 134 participants 159 participants 528 participants 43 participants 140 participants 1737 participants
38  (4.0) 62  (11.0) 39  (4.0) 62  (9.0) 38  (3.0) 62  (10.0) 38  (3.0) 61  (9.0) 50.0  (6.6)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 515 participants 42 participants 134 participants 159 participants 528 participants 43 participants 140 participants 1737 participants
Female
85
  48.3%
240
  46.6%
19
  45.2%
67
  50.0%
79
  49.7%
252
  47.7%
16
  37.2%
78
  55.7%
836
  48.1%
Male
91
  51.7%
275
  53.4%
23
  54.8%
67
  50.0%
80
  50.3%
276
  52.3%
27
  62.8%
62
  44.3%
901
  51.9%
1.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame Throughout the entire study period: from Month 21 to Month 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects vaccinated in the primary NCT00197041 study, and re- enrolled in this follow-up NCT 00323622 study, and for whom data were available.
Arm/Group Title Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Hide Arm/Group Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Overall Number of Participants Analyzed 176 515 42 134 159 528 43 140
Measure Type: Number
Unit of Measure: Subjects
21 17 1 0 24 29 1 4
2.Secondary Outcome
Title Anti-circumsporozoite Protein (CS) Antibody Concentrations.
Hide Description Concentrations for anti-CS antibodies are presented as Geometric Mean Concentrations (GMCs), expressed in Enzyme-Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL). The cut-off of the assay was the seropositivity cut-off of 0.5 EL.U/mL. Subjects were pooled across age ranges for this outcome measure.
Time Frame At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).
Hide Outcome Measure Data
Hide Analysis Population Description
The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens, with blood sample within protocol-defined time limits and available antibody measurements
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group Cohort 2-RTS,S/AS02A Group Cohort 2-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Overall Number of Participants Analyzed 490 487 150 149
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Month 33 [N = 490, 487, 149, 149]
10.1
(8.9 to 11.4)
NA [1] 
(NA to NA)
16.2
(13.1 to 20.0)
0.6
(0.5 to 0.7)
Month 45 [N = 452, 447, 150, 145]
8.9
(7.8 to 10.1)
NA [1] 
(NA to NA)
15.4
(12.7 to 18.6)
0.4
(0.4 to 0.5)
[1]
GMC were not calculated as concentration fell below the assay cut-off
3.Secondary Outcome
Title Anti-hepatitis B (HBs) Antibody Concentrations.
Hide Description Concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL). Anti-HBs antibody concentration levels were measured in blood samples from Cohort 2 only.
Time Frame At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).
Hide Outcome Measure Data
Hide Analysis Population Description
The Long Term According-to-Protocol (ATP) cohort for immunogenicity included all enrolled subjects from the primary study ATP cohort for immunogenicity who did not receive any additional vaccine dose containing circumsporozoite protein or hepatitis B antigens,with blood sample within protocol-defined time limits and available antibody measurements.
Arm/Group Title Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Hide Arm/Group Description:
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
Overall Number of Participants Analyzed 35 116 34 115
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Month 33 [N = 33, 116, 34, 115]
4008.6
(2266.7 to 7089.1)
1842.5
(1413.7 to 2401.3)
20.3
(10.9 to 37.9)
67.4
(47.5 to 95.7)
Month 45 [N = 35, 115, 32, 113]
3323.8
(1908.4 to 5788.8)
1557.0
(1187.6 to 2041.4)
26.6
(13.0 to 54.1)
99.4
(73.1 to 135.1)
4.Secondary Outcome
Title Time to First or Only Clinical Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Primary Case Definition
Hide Description Malaria infection by Plasmodium falciparum was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.
Time Frame From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041
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Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: n/PYAR
RPFMI – PCD - M21-33 (N=650;645) 0.330 0.375
RPFMI – PCD - M33-45 (N=638;629) 0.140 0.149
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 - GSK RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (HR1/HR2)
Estimated Value 16.8
Confidence Interval (2-Sided) 95%
-2.50 to 32.40
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (HR1/HR2)
Estimated Value 11.8
Confidence Interval (2-Sided) 95%
-20.11 to 35.18
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 1
Hide Description PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 1 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was solely performed on Cohort 1 subjects, with groups pooled across age ranges.
Time Frame From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: n/PYAR
RPFMI – SCD 1 - M21-33 (N=650;645) 0.365 0.409
RPFMI – SCD 1 - M33-45 (N=638;629) 0.161 0.174
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 14.90
Confidence Interval (2-Sided) 95%
-3.88 to 30.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 12.79
Confidence Interval (2-Sided) 95%
-16.27 to 34.59
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 2
Hide Description PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 2 was defined as the presence of P. falciparum asexual parasitaemia (any level if parasitemia) on Giemsa stained thick blood films in an unwell child brought for treatment with a history of fever (axillary temperature equal or above 37.5 degrees Celsius) within 24 hours or documented fever. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects, with groups pooled across age ranges.
Time Frame From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: n/PYAR
RPFMI – SCD 2 - M21-33 (N=650;645) 0.540 0.630
RPFMI – SCD 2 - M33-45 (N=638;629) 0.260 0.270
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 19.42
Confidence Interval (2-Sided) 95%
4.62 to 31.93
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 7.08
Confidence Interval (2-Sided) 95%
-17.37 to 26.44
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time to First or Only Episode of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI) of Secondary Case Definition 3
Hide Description PFMI was detected by passive case detection. Symptomatic PFMI of Secondary Case Definition (SCD) 3 was defined as the presence of P. falciparum asexual parasitaemia above 15000 per microliter (µL) on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius) in an unwell child brought for treatment to a healthcare facility. The time to first or only episode of symptomatic PFMI is expressed in terms of rate of first PFMI (RPFMI), that is, the number of PFMI events reported (n) over the period elapsed until the PFMI event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.
Time Frame From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: n/PYAR
RPFMI – SCD 3 - M21-33 (N=650;645) 0.288 0.329
RPFMI – SCD 3 - M33-45 (N=638;629) 0.122 0.122
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 21-33 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 16.79
Confidence Interval (2-Sided) 95%
-3.75 to 33.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 1-RTS,S/AS02A Group, Cohort 1-Engerix-B/Prevnar-Hiberix Group
Comments The analysis aimed to compare rates of first PFMI (RPFMI) between groups over the Months 33-45 time period. Using RFPMI, a Cox model was used to evaluate vaccine efficacy (VE) allowing for adjustment factors. VE, point estimate of efficacy adjusted for covariates, was calculated as 1 – (minus) [Hazard Ratio (HR) in Cohort 1 – RTS,S/AS02A Group [HR1]) divided by HR in Cohort 1 - Engerix-B/Prevnar-Hiberix Group [HR2])], i. e. 1 - (HR1/HR2).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments The p-value presented is the Wald Chi-square p-value from the Cox regression model.
Method Regression, Cox
Comments Point estimate of efficacy was adjusted for age, geographical area of residence, bednet use and distance from health center.
Method of Estimation Estimation Parameter 1 - (R1/R2)
Estimated Value 6.31
Confidence Interval (2-Sided) 95%
-31.00 to 32.99
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Primary Case Definition Clinical Episodes of Symptomatic Plasmodium Falciparum Malaria Infection (PFMI)
Hide Description PFMI was detected by passive case detection. A symptomatic PFMI episode of Primary Case Definition (PCD) was defined as the presence of P. falciparum asexual parasitaemia above 2500 per µL on Giemsa stained thick blood films accompanied by fever (axillary temperature equal or above 37.5 degrees Celsius at the time of presentation) occurring in an unwell child brought for treatment to a healthcare facility. The number of PFMI episodes (EPFMI) per person-year (pyr) was tabulated, using as unit EPFMI episode per pyr. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.
Time Frame From Month 21 to Month 33 (M21-33), and from Month 33 to Month 45 (M33-45). Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in study NCT00197041
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: EPFMI episode per pyr
EPFMI – PCD - M21-33 (N=650;645) 252 291
EPFMI – PCD - M33-45 (N=638;629) 99 100
9.Secondary Outcome
Title Number of Subjects With Anemia.
Hide Description Anemia was indicated by a hematocrit level (HL) below (<) 25%. The numbers of subjects with HL below (<) and above or equal (≥) 25 %, and with missing HL results were tabulated. In the tabulation below, the number of subjects falling into the “HL ≥25%” category corresponds to the number of subjects with anemia as asked per outcome. Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.
Time Frame At Months 33 and 45 (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 650 645
Measure Type: Number
Unit of Measure: Subjects
HL <25%, Month 33 (N = 650, 645) 2 2
HL ≥25%, Month 33 (N = 650, 645]) 584 593
Missing Results, Month 33 (N = 650;645) 64 50
HL <25%, Month 45 (N = 638, 629) 0 0
HL ≥25%, Month 45 (N = 638, 629) 540 543
Missing Results, Month 45 (N = 638;629) 98 86
10.Secondary Outcome
Title Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum) Parasitemia
Hide Description Subjects prevalent for P. falciparum parasitemia were defined as subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films.Analysis for this outcome was performed on Cohort 1 subjects solely, with groups pooled across age ranges.
Time Frame At Months 33 (M33) and 45 (M45) (Month 0 = administration of Dose 1 of RTS,S/AS02A or comparator vaccine in the NCT00197041 study).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects who had received the 3 doses of the RTS,S/AS02 or control vaccine(s) in the Primary NCT00197041, and with available data concerning efficacy measures starting 14 days post Dose 3 of RTS,S/AS02A or comparator vaccine(s).
Arm/Group Title Cohort 1-RTS,S/AS02A Group Cohort 1-Engerix-B/Prevnar-Hiberix Group
Hide Arm/Group Description:
Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
Overall Number of Participants Analyzed 590 596
Measure Type: Number
Unit of Measure: Subjects
Subjects prevalent for parasitemia, M33[N=590,590] 93 121
Subjects prevalent for parasitemia, M45[N=541,547] 66 101
Time Frame SAE reports were collected from 21 to 45 months post Dose 1 of either vaccine.
Adverse Event Reporting Description No reports of solicited symptoms or unsolicited AEs were collected during this study. Fatal SAEs were reported for a total of 11 subjects (1 in the Cohort 1-RTS,S/AS02A <24M Group, 1 in the Cohort 1-RTS,S/AS02A ≥24M Group, 7 in the Cohort 1-Prevnar-Hiberix <24M Group and 2 in the Cohort 2-Engerix-B ≥24M Group)
 
Arm/Group Title Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Hide Arm/Group Description Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection. Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
All-Cause Mortality
Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/176 (11.93%)   17/515 (3.30%)   1/42 (2.38%)   0/134 (0.00%)   24/159 (15.09%)   29/528 (5.49%)   1/43 (2.33%)   4/140 (2.86%) 
Blood and lymphatic system disorders                 
Anemia * 1 [1]  12/176 (6.82%)  8/515 (1.55%)  1/42 (2.38%)  0/134 (0.00%)  14/159 (8.81%)  9/528 (1.70%)  0/43 (0.00%)  1/140 (0.71%) 
Eye disorders                 
Conjunctivitis *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
General disorders                 
Death *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  1/140 (0.71%) 
Hepatobiliary disorders                 
Hepatitis acute *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Immune system disorders                 
Immunosuppression * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Infections and infestations                 
Ascariasis *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Bronchopneumonia *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Cellulitis *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  1/528 (0.19%)  0/43 (0.00%)  1/140 (0.71%) 
Encephalitis viral *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Haemophilus sepsis *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Malaria * [2]  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  2/528 (0.38%)  0/43 (0.00%)  0/140 (0.00%) 
Oral candidiasis *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Pneumococcal sepsis *  2/176 (1.14%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Sepsis *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Tinea capitis *  0/176 (0.00%)  2/515 (0.39%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Upper respiratory tract infection *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Cellulitis orbital *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Cerebral malaria * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Fungal skin infection *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Gastroenteritis * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  2/159 (1.26%)  2/528 (0.38%)  0/43 (0.00%)  0/140 (0.00%) 
Herpes simplex *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Otitis media *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Pulmonary tuberculosis * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Pyoderma *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Salmonella sepsis * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Streptococcal bacteremia *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Acquired immunodeficiency syndrome * [3]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  2/159 (1.26%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
HIV Infection * 1 [4]  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Plasmodium falciparum infection * 1 [5]  20/176 (11.36%)  14/515 (2.72%)  1/42 (2.38%)  0/134 (0.00%)  18/159 (11.32%)  19/528 (3.60%)  1/43 (2.33%)  2/140 (1.43%) 
Pneumonia * 1 [6]  2/176 (1.14%)  2/515 (0.39%)  0/42 (0.00%)  0/134 (0.00%)  3/159 (1.89%)  3/528 (0.57%)  0/43 (0.00%)  0/140 (0.00%) 
Injury, poisoning and procedural complications                 
Brain contusion *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Tibia fracture *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Forearm fracture *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Subcutaneous haematoma *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Thermal burn * [7]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  1/140 (0.71%) 
Investigations                 
Platelet count decreased * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Metabolism and nutrition disorders                 
Kwashiorkor * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Underweight *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  1/528 (0.19%)  0/43 (0.00%)  0/140 (0.00%) 
Marasmus * 1 [4]  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Nervous system disorders                 
Convulsion * [2]  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Febrile convulsion *  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  5/159 (3.14%)  7/528 (1.33%)  1/43 (2.33%)  1/140 (0.71%) 
Respiratory, thoracic and mediastinal disorders                 
Bronchospasm * [2]  0/176 (0.00%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Skin and subcutaneous tissue disorders                 
Dermatitis *  0/176 (0.00%)  1/515 (0.19%)  0/42 (0.00%)  0/134 (0.00%)  1/159 (0.63%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
Urticaria *  1/176 (0.57%)  0/515 (0.00%)  0/42 (0.00%)  0/134 (0.00%)  0/159 (0.00%)  0/528 (0.00%)  0/43 (0.00%)  0/140 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A <24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group, and 3 subjects in the Cohort 1-Prevnar-Hiberix <24M Group
[2]
This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix <24M Group.
[3]
This SAE was fatal for 2 subjects in the Cohort 1-Prevnar-Hiberix <24M Group.
[4]
This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group.
[5]
Occurrences of this SAE were fatal for one subject in the Cohort 1-RTS,S/AS02A <24M Group, one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 2 subjects in the Cohort 1-Prevnar-Hiberix <24M Group
[6]
This SAE was fatal for one subject in the Cohort 1-RTS,S/AS02A ≥24M Group and 3 subjects in the Cohort 1-Prevnar-Hiberix <24M Group.
[7]
This SAE was fatal for one subject in the Cohort 1-Prevnar-Hiberix <24M Group and one subject in the Cohort 2-Engerix-B ≥24M Group
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1-RTS,S/AS02A <24M Group Cohort 1-RTS,S/AS02A ≥24M Group Cohort 2-RTS,S/AS02A <24M Group Cohort 2-RTS,S/AS02A ≥24M Group Cohort 1-Prevnar-Hiberix <24M Group Cohort 1-Engerix-B ≥24M Group Cohort 2-Prevnar- Hiberix <24M Group Cohort 2-Engerix-B ≥24M Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)   0/515 (0.00%)   0/42 (0.00%)   0/134 (0.00%)   0/159 (0.00%)   0/528 (0.00%)   0/43 (0.00%)   0/140 (0.00%) 
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
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00323622     History of Changes
Other Study ID Numbers: 104297
First Submitted: September 8, 2005
First Posted: May 9, 2006
Results First Submitted: March 29, 2013
Results First Posted: March 27, 2014
Last Update Posted: December 9, 2016