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Trial record 8 of 68 for:    Diseases | ( Map: Mozambique )

Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region

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ClinicalTrials.gov Identifier: NCT00197028
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 18, 2013
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Malaria
Interventions Biological: RTS,S/AS02D
Biological: TETRActHib™
Biological: Engerix-B®
Enrollment 214
Recruitment Details  
Pre-assignment Details The study comprised 2 phases, a double-blind vaccination phase from Month 0 to Month 6, and a single-blind phase (Month 7 to Month 14).
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Period Title: Overall Study
Started 107 107
Completed 91 86
Not Completed 16 21
Reason Not Completed
Adverse Event             2             2
Protocol Violation             2             1
Withdrawal by Subject             8             12
Lost to Follow-up             1             0
Other             3             6
Arm/Group Title RTS,S/AS02D Group Engerix-B Group Total
Hide Arm/Group Description Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. Total of all reporting groups
Overall Number of Baseline Participants 107 107 214
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 107 participants 107 participants 214 participants
8.3  (1.42) 8.3  (1.08) 8.3  (1.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 107 participants 214 participants
Female
48
  44.9%
59
  55.1%
107
  50.0%
Male
59
  55.1%
48
  44.9%
107
  50.0%
1.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame From Month 0 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: subjects
17 17
2.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs).
Hide Description SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time Frame Throughout the entire study period (from Month 0 to Month 14)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: subjects
35 34
3.Secondary Outcome
Title Concentrations of Antibodies Against Hepatitis B (Anti-HB)
Hide Description Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The seroprotection cut-off of the assay was 10 mIU/mL.
Time Frame Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 72 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HB, PRE [N=72;70]
14.0
(9.6 to 20.5)
16.6
(11.0 to 25.0)
Anti-HB, Day 104 [N=68;64]
10081.6
(7394.9 to 13744.4)
392.4
(297.0 to 518.5)
4.Secondary Outcome
Title Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies.
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations are expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 0.5 EL.U/mL.
Time Frame Prior to vaccination at Month 0 (PRE), 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104) and 3½ months post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 180).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 76 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-CS, PRE [N=76;77]
0.4
(0.3 to 0.5)
0.4
(0.3 to 0.4)
Anti-CS, Day 104 [N=71;68]
199.9
(150.9 to 264.7)
0.3
(0.2 to 0.3)
Anti-CS, Day 180 [N=53;61]
58.8
(41.8 to 82.8)
0.4
(0.3 to 0.5)
5.Secondary Outcome
Title Concentrations of Antibodies Against Anti-diphtheria (Anti-D)
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 73 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
1.4
(1.1 to 1.7)
1.4
(1.2 to 1.7)
6.Secondary Outcome
Title Concentrations of Antibodies Against Tetanus (Anti-T)
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in international unit per milliliter (IU/mL). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 73 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
6.2
(5.0 to 7.7)
5.1
(4.2 to 6.3)
7.Secondary Outcome
Title Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA unit per milliliter (EL.U/mL). The seropositivity cut-off of the assay was 15 EL.U/mL.
Time Frame At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 72 70
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
104.4
(89.1 to 122.4)
106.8
(93.3 to 122.1)
8.Secondary Outcome
Title Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).
Hide Description Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was 0.15 µg/mL.
Time Frame At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 73 72
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
22.1
(16.3 to 29.9)
17.9
(13.5 to 23.6)
9.Secondary Outcome
Title Time to First Malaria Infection
Hide Description Malaria infection by Plasmodium falciparum (P. falciparum) was detected by active detection of infection (ADI) and passive case detection (PCD), and was defined as the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films. The time to first malaria infection is expressed in terms of rate of first malaria infection, that is, the number of malaria infection events reported (n) over the period elapsed until the event occurred (i.e. events per Persons Year at Risk [PYAR]) for each group.
Time Frame Over the period starting 14 days after Dose 3 of RTS,S/AS02D or Engerix-B® vaccine and extending for 12 weeks thereafter (from Month 2.5 to Month 6)
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 (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 93 92
Measure Type: Number
Unit of Measure: n/PYAR
1.01 2.67
10.Secondary Outcome
Title Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)
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.
Time Frame At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)
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 (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 88 90
Measure Type: Number
Unit of Measure: subjects
4 7
11.Secondary Outcome
Title Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia
Hide Description The parasite density in subjects prevalent for P. falciparum parasitemia (subjects with the presence of P. falciparum asexual parasitemia above 0 per microliter (µL) on Giemsa stained thick blood films), was detected at a cross sectional time point 3 ½ months after administration of Dose 3 of RTS,S/AS02D or Engerix-B® vaccine (Month 6). Parasite density is expressed as mean, minimum and maximum density in parasite per µL.
Time Frame At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)
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 (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom data concerning efficacy outcome variables were available.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 4 7
Mean (Full Range)
Unit of Measure: Parasites per µL
11573
(131 to 33471)
10612
(89 to 31993)
12.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain and swelling at injection site.
Time Frame During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: subjects
Pain 107 107
Swelling 39 47
13.Secondary Outcome
Title Number of Subjects With Solicited Local Symptoms.
Hide Description Assessed solicited local symptoms were pain and swelling at injection site.
Time Frame During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 105 106
Measure Type: Number
Unit of Measure: subjects
Pain 105 105
Swelling 26 23
14.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).
Time Frame During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: subjects
Dorwsiness 64 58
Fever ≥ 37.5°C 24 25
Irritability 89 88
Loss of appetite 58 49
15.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms.
Hide Description Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite. Fever was defined as axillary temperature equal or above (≥) to 37.5 degrees Celsius (C).
Time Frame During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 105 106
Measure Type: Number
Unit of Measure: subjects
Drowsiness 60 69
Fever ≥ 37.5°C 25 23
Irritability 81 81
Loss of appetite 53 62
16.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE is any AE (i.e. any 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 During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 107 107
Measure Type: Number
Unit of Measure: subjects
64 51
17.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE is any AE (i.e. any 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 During the 14 day (Days 0-13) follow-up period after vaccination with any among Doses 1 and 2 of Engerix-B® or RTS,S/AS02D vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 105 106
Measure Type: Number
Unit of Measure: subjects
50 47
18.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs).
Hide Description An unsolicited AE is any AE (i.e. any 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 During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available, and whose symptom sheet was completed.
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description:
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Number of Participants Analyzed 97 97
Measure Type: Number
Unit of Measure: subjects
32 39
Time Frame SAEs: entire study period (Months 0-14); Unsolicited AEs: Days 0-13 or 0-29 periods (as specified in notes); Solicited local/general symptoms: 7 day (Days 0-6) follow-up period after any vaccination.
Adverse Event Reporting Description For solicited symptoms and unsolicited AEs assessed following vaccination, the number of participants at risk included those vaccinated subjects from the Total Vaccinated cohort who had the symptom sheet completed.
 
Arm/Group Title RTS,S/AS02D Group Engerix-B Group
Hide Arm/Group Description Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh. Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
All-Cause Mortality
RTS,S/AS02D Group Engerix-B Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RTS,S/AS02D Group Engerix-B Group
Affected / at Risk (%) Affected / at Risk (%)
Total   35/107 (32.71%)   34/107 (31.78%) 
Blood and lymphatic system disorders     
Anaemia *  17/107 (15.89%)  13/107 (12.15%) 
Eye disorders     
Conjunctivitis *  0/107 (0.00%)  1/107 (0.93%) 
General disorders     
Pyrexia *  0/107 (0.00%)  2/107 (1.87%) 
Infections and infestations     
Gastroenteritis *  13/107 (12.15%)  18/107 (16.82%) 
Plasmodium falciparum infection *  15/107 (14.02%)  13/107 (12.15%) 
Bronchopneumonia *  4/107 (3.74%)  5/107 (4.67%) 
Bronchitis *  3/107 (2.80%)  4/107 (3.74%) 
Pneumonia *  4/107 (3.74%)  3/107 (2.80%) 
Oral candidiasis *  2/107 (1.87%)  1/107 (0.93%) 
Otitis media *  1/107 (0.93%)  2/107 (1.87%) 
Upper respiratory tract infection *  1/107 (0.93%)  3/107 (2.80%) 
Pyoderma *  1/107 (0.93%)  2/107 (1.87%) 
Ascariasis *  0/107 (0.00%)  1/107 (0.93%) 
Furuncle *  0/107 (0.00%)  1/107 (0.93%) 
Malaria *  1/107 (0.93%)  0/107 (0.00%) 
Mastoiditis *  0/107 (0.00%)  1/107 (0.93%) 
Pneumococcal sepsis *  1/107 (0.93%)  0/107 (0.00%) 
Pneumonia pneumococcal *  1/107 (0.93%)  0/107 (0.00%) 
Septic shock *  1/107 (0.93%)  0/107 (0.00%) 
Staphylococcal sepsis *  1/107 (0.93%)  0/107 (0.00%) 
Tinea capitis *  0/107 (0.00%)  1/107 (0.93%) 
Tonsillitis *  1/107 (0.93%)  0/107 (0.00%) 
Injury, poisoning and procedural complications     
Thermal burn *  0/107 (0.00%)  1/107 (0.93%) 
Investigations     
Hepatic enzyme increased *  0/107 (0.00%)  1/107 (0.93%) 
Metabolism and nutrition disorders     
Dehydration *  4/107 (3.74%)  3/107 (2.80%) 
Marasmus *  2/107 (1.87%)  2/107 (1.87%) 
Nervous system disorders     
Febrile convulsion *  1/107 (0.93%)  1/107 (0.93%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm *  0/107 (0.00%)  2/107 (1.87%) 
Bronchial hyper reactivity *  1/107 (0.93%)  0/107 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis *  0/107 (0.00%)  1/107 (0.93%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RTS,S/AS02D Group Engerix-B Group
Affected / at Risk (%) Affected / at Risk (%)
Total   107/107 (100.00%)   107/107 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * [1]  11/107 (10.28%)  4/107 (3.74%) 
Eye disorders     
Conjunctivitis * [2]  7/107 (6.54%)  2/107 (1.87%) 
Gastrointestinal disorders     
Diarrhea * [1]  17/107 (15.89%)  6/107 (5.61%) 
Diarrhea * [3]  8/105 (7.62%)  8/106 (7.55%) 
Diarrhea * [4]  6/97 (6.19%)  6/97 (6.19%) 
General disorders     
Pain  [5]  107/107 (100.00%)  107/107 (100.00%) 
Swelling  [5]  39/107 (36.45%)  47/107 (43.93%) 
Drowsiness  [1]  64/107 (59.81%)  58/107 (54.21%) 
Fever  [1]  24/107 (22.43%)  25/107 (23.36%) 
Irritability  [1]  89/107 (83.18%)  88/107 (82.24%) 
Loss of appetite  [1]  58/107 (54.21%)  49/107 (45.79%) 
Pyrexia * [4]  5/97 (5.15%)  3/97 (3.09%) 
Pain  [6]  105/105 (100.00%)  105/106 (99.06%) 
Swelling  [6]  26/105 (24.76%)  23/106 (21.70%) 
Drowsiness  [6]  60/105 (57.14%)  69/106 (65.09%) 
Fever  [6]  25/105 (23.81%)  23/106 (21.70%) 
Irritability  [6]  81/105 (77.14%)  81/106 (76.42%) 
Loss of appetite  [6]  53/105 (50.48%)  62/106 (58.49%) 
Infections and infestations     
Upper respiratory tract infection * [1]  26/107 (24.30%)  18/107 (16.82%) 
Malaria * [1]  14/107 (13.08%)  7/107 (6.54%) 
Bronchitis * [1]  7/107 (6.54%)  5/107 (4.67%) 
Upper respiratory tract infection * [7]  21/105 (20.00%)  24/106 (22.64%) 
Upper respiratory tract infection * [8]  7/97 (7.22%)  15/97 (15.46%) 
Malaria * [3]  3/105 (2.86%)  7/106 (6.60%) 
Malaria * [9]  0/97 (0.00%)  7/97 (7.22%) 
Ear infection * [1]  3/107 (2.80%)  6/107 (5.61%) 
Respiratory, thoracic and mediastinal disorders     
Cough * [1]  13/107 (12.15%)  10/107 (9.35%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
During the 14-day follow-up period after vaccination with TETRAct/Hib vaccine
[2]
During the 14-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
[3]
During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-B® vaccine
[4]
During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-B® vaccine
[5]
During the 7-day follow-up period after vaccination with TETRAct/Hib vaccine
[6]
During the 7-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
[7]
During the 14-day follow-up period after vaccination with Doses 1 and 2 of RTS,S/AS02D or Engerix-BTM vaccine
[8]
During the 29-day follow-up period after vaccination with Dose 3 of RTS,S/AS02D or Engerix-BTM vaccine
[9]
During the 30-day follow-up period after vaccination with RTS,S/AS02D or Engerix-B® vaccine
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: NCT00197028     History of Changes
Other Study ID Numbers: 103967
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: December 13, 2012
Results First Posted: January 18, 2013
Last Update Posted: August 20, 2018