Trial Outcomes & Findings for Examine Safety and Immune Responses of GSK 257049 Vaccine When Administered to Infants Living in a Malaria-endemic Region (NCT NCT00197028)

NCT ID: NCT00197028

Last Updated: 2018-08-20

Results Overview

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 214 participants
• Primary outcome timeframe: From Month 0 to Month 6
• Results posted on: 2018-08-20

Participant Flow

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).

Participant milestones

Measure	RTS,S/AS02D Group 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.	Engerix-B Group 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 Study STARTED	107	107
Overall Study COMPLETED	91	86
Overall Study NOT COMPLETED	16	21

Reasons for withdrawal

Measure	RTS,S/AS02D Group 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.	Engerix-B Group 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 Study Adverse Event	2	2
Overall Study Protocol Violation	2	1
Overall Study Withdrawal by Subject	8	12
Overall Study Lost to Follow-up	1	0
Overall Study Other	3	6

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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 n=214 Participants Total of all reporting groups
Age, Continuous	8.3 Weeks STANDARD_DEVIATION 1.42 • n=5 Participants	8.3 Weeks STANDARD_DEVIATION 1.08 • n=7 Participants	8.3 Weeks STANDARD_DEVIATION 1.25 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	59 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	48 Participants n=7 Participants	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Month 0 to Month 6

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs).	17 subjects	17 subjects

SECONDARY outcome

Timeframe: Throughout the entire study period (from Month 0 to Month 14)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.

SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.

Outcome measures

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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.
Number of Subjects With Serious Adverse Events (SAEs).	35 subjects	34 subjects

SECONDARY outcome

Timeframe: Prior to vaccination at Month 0 (PRE) and 1 month post Dose 3 of Engerix-B® or RTS,S/AS02D vaccine (Day 104).

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=72 Participants 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.	Engerix-B Group n=70 Participants 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.
Concentrations of Antibodies Against Hepatitis B (Anti-HB) Anti-HB, PRE [N=72;70]	14.0 mIU/mL Interval 9.6 to 20.5	16.6 mIU/mL Interval 11.0 to 25.0
Concentrations of Antibodies Against Hepatitis B (Anti-HB) Anti-HB, Day 104 [N=68;64]	10081.6 mIU/mL Interval 7394.9 to 13744.4	392.4 mIU/mL Interval 297.0 to 518.5

SECONDARY outcome

Timeframe: 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).

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=76 Participants 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.	Engerix-B Group n=77 Participants 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.
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies. Anti-CS, PRE [N=76;77]	0.4 EL.U/mL Interval 0.3 to 0.5	0.4 EL.U/mL Interval 0.3 to 0.4
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies. Anti-CS, Day 104 [N=71;68]	199.9 EL.U/mL Interval 150.9 to 264.7	0.3 EL.U/mL Interval 0.2 to 0.3
Concentrations of Anti-circumsporozoite Protein (Anti-CS) Antibodies. Anti-CS, Day 180 [N=53;61]	58.8 EL.U/mL Interval 41.8 to 82.8	0.4 EL.U/mL Interval 0.3 to 0.5

SECONDARY outcome

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=73 Participants 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.	Engerix-B Group n=72 Participants 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.
Concentrations of Antibodies Against Anti-diphtheria (Anti-D)	1.4 IU/mL Interval 1.1 to 1.7	1.4 IU/mL Interval 1.2 to 1.7

SECONDARY outcome

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=73 Participants 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.	Engerix-B Group n=72 Participants 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.
Concentrations of Antibodies Against Tetanus (Anti-T)	6.2 IU/mL Interval 5.0 to 7.7	5.1 IU/mL Interval 4.2 to 6.3

SECONDARY outcome

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=72 Participants 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.	Engerix-B Group n=70 Participants 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.
Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT).	104.4 EL.U/mL Interval 89.1 to 122.4	106.8 EL.U/mL Interval 93.3 to 122.1

SECONDARY outcome

Timeframe: At Day 90 (1 month post Dose 3 of TETRActHib™ vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=73 Participants 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.	Engerix-B Group n=72 Participants 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.
Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP).	22.1 µg/mL Interval 16.3 to 29.9	17.9 µg/mL Interval 13.5 to 23.6

SECONDARY outcome

Timeframe: 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)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=93 Participants 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.	Engerix-B Group n=92 Participants 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.
Time to First Malaria Infection	1.01 n/PYAR	2.67 n/PYAR

SECONDARY outcome

Timeframe: At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=88 Participants 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.	Engerix-B Group n=90 Participants 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.
Number of Subjects Prevalent for Plasmodium Falciparum (P. Falciparum)	4 subjects	7 subjects

SECONDARY outcome

Timeframe: At Month 6 (3½ months post Dose 3 of RTS,S/AS02D or Engerix-B® vaccine)

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=4 Participants 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.	Engerix-B Group n=7 Participants 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.
Plasmodium Falciparum (P. Falciparum) Parasite Density in Subjects Prevalent for Parasitemia	11573 Parasites per µL Interval 131.0 to 33471.0	10612 Parasites per µL Interval 89.0 to 31993.0

SECONDARY outcome

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine.

Population: 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.

Assessed solicited local symptoms were pain and swelling at injection site.

Outcome measures

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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.
Number of Subjects With Solicited Local Symptoms. Pain	107 subjects	107 subjects
Number of Subjects With Solicited Local Symptoms. Swelling	39 subjects	47 subjects

SECONDARY outcome

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine.

Population: 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.

Assessed solicited local symptoms were pain and swelling at injection site.

Outcome measures

Measure	RTS,S/AS02D Group n=105 Participants 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.	Engerix-B Group n=106 Participants 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.
Number of Subjects With Solicited Local Symptoms. Pain	105 subjects	105 subjects
Number of Subjects With Solicited Local Symptoms. Swelling	26 subjects	23 subjects

SECONDARY outcome

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with TETRActHib™ vaccine

Population: 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.

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).

Outcome measures

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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.
Number of Subjects With Solicited General Symptoms. Dorwsiness	64 subjects	58 subjects
Number of Subjects With Solicited General Symptoms. Fever ≥ 37.5°C	24 subjects	25 subjects
Number of Subjects With Solicited General Symptoms. Irritability	89 subjects	88 subjects
Number of Subjects With Solicited General Symptoms. Loss of appetite	58 subjects	49 subjects

SECONDARY outcome

Timeframe: During the 7 day (Days 0-6) follow-up period after any vaccination with Engerix-B® or RTS,S/AS02D vaccine

Population: 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.

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).

Outcome measures

Measure	RTS,S/AS02D Group n=105 Participants 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.	Engerix-B Group n=106 Participants 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.
Number of Subjects With Solicited General Symptoms. Loss of appetite	53 subjects	62 subjects
Number of Subjects With Solicited General Symptoms. Drowsiness	60 subjects	69 subjects
Number of Subjects With Solicited General Symptoms. Fever ≥ 37.5°C	25 subjects	23 subjects
Number of Subjects With Solicited General Symptoms. Irritability	81 subjects	81 subjects

SECONDARY outcome

Timeframe: During the 14 day (Days 0-13) follow-up period after any vaccination with of TETRActHib™ vaccine

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=107 Participants 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.	Engerix-B Group n=107 Participants 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.
Number of Subjects With Unsolicited Adverse Events (AEs).	64 subjects	51 subjects

SECONDARY outcome

Timeframe: 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.

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=105 Participants 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.	Engerix-B Group n=106 Participants 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.
Number of Subjects With Unsolicited Adverse Events (AEs).	50 subjects	47 subjects

SECONDARY outcome

Timeframe: During the 30 day (Days 0-29) follow-up period after vaccination with Dose 3 of Engerix-B® or RTS,S/AS02D vaccine.

Population: 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.

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.

Outcome measures

Measure	RTS,S/AS02D Group n=97 Participants 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.	Engerix-B Group n=97 Participants 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.
Number of Subjects With Unsolicited Adverse Events (AEs).	32 subjects	39 subjects

Adverse Events

RTS,S/AS02D Group

Serious events: 35 serious events

Other events: 107 other events

Deaths: 0 deaths

Engerix-B Group

Serious events: 34 serious events

Other events: 107 other events

Deaths: 0 deaths

Serious adverse events

Measure	RTS,S/AS02D Group n=107 participants at risk 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.	Engerix-B Group n=107 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/107 • 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. 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.	1.9% 2/107 • 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. 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.
Nervous system disorders Febrile convulsion	0.93% 1/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Pyoderma	0.93% 1/107 • 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. 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.	1.9% 2/107 • 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. 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.
General disorders Pyrexia	0.00% 0/107 • 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. 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.	1.9% 2/107 • 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. 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.
Infections and infestations Ascariasis	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Respiratory, thoracic and mediastinal disorders Bronchial hyper reactivity	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Eye disorders Conjunctivitis	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Furuncle	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Malaria	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Infections and infestations Mastoiditis	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Pneumococcal sepsis	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Infections and infestations Gastroenteritis	12.1% 13/107 • 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. 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.	16.8% 18/107 • 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. 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.
Blood and lymphatic system disorders Anaemia	15.9% 17/107 • 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. 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.	12.1% 13/107 • 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. 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.
Infections and infestations Plasmodium falciparum infection	14.0% 15/107 • 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. 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.	12.1% 13/107 • 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. 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.
Infections and infestations Bronchopneumonia	3.7% 4/107 • 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. 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.	4.7% 5/107 • 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. 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.
Infections and infestations Bronchitis	2.8% 3/107 • 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. 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.	3.7% 4/107 • 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. 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.
Metabolism and nutrition disorders Dehydration	3.7% 4/107 • 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. 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.	2.8% 3/107 • 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. 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.
Infections and infestations Pneumonia	3.7% 4/107 • 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. 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.	2.8% 3/107 • 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. 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.
Metabolism and nutrition disorders Marasmus	1.9% 2/107 • 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. 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.	1.9% 2/107 • 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. 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.
Infections and infestations Oral candidiasis	1.9% 2/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Otitis media	0.93% 1/107 • 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. 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.	1.9% 2/107 • 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. 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.
Infections and infestations Upper respiratory tract infection	0.93% 1/107 • 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. 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.	2.8% 3/107 • 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. 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.
Infections and infestations Pneumonia pneumococcal	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Infections and infestations Septic shock	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Infections and infestations Staphylococcal sepsis	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Infections and infestations Tinea capitis	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Infections and infestations Tonsillitis	0.93% 1/107 • 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. 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.	0.00% 0/107 • 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. 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.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.
Investigations Hepatic enzyme increased	0.00% 0/107 • 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. 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.	0.93% 1/107 • 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. 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.

Other adverse events

Measure	RTS,S/AS02D Group n=107 participants at risk 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.	Engerix-B Group n=107 participants at risk 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.
General disorders Drowsiness	57.1% 60/105 • 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. 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.	54.2% 58/107 • 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. 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.
General disorders Pain	100.0% 105/105 • 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. 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.	99.1% 105/106 • 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. 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.
General disorders Swelling	24.8% 26/105 • 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. 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.	21.7% 23/106 • 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. 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.
General disorders Fever	23.8% 25/105 • 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. 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.	21.7% 23/106 • 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. 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.
General disorders Irritability	77.1% 81/105 • 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. 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.	76.4% 81/106 • 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. 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.
General disorders Loss of appetite	50.5% 53/105 • 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. 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.	58.5% 62/106 • 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. 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.
Infections and infestations Upper respiratory tract infection	7.2% 7/97 • 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. 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.	15.5% 15/97 • 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. 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.
Respiratory, thoracic and mediastinal disorders Cough	12.1% 13/107 • 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. 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.	9.3% 10/107 • 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. 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.
Infections and infestations Malaria	0.00% 0/97 • 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. 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.	7.2% 7/97 • 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. 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.
Infections and infestations Bronchitis	6.5% 7/107 • 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. 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.	4.7% 5/107 • 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. 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.
Blood and lymphatic system disorders Anaemia	10.3% 11/107 • 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. 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.	3.7% 4/107 • 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. 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.
Eye disorders Conjunctivitis	6.5% 7/107 • 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. 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.	1.9% 2/107 • 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. 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.
Gastrointestinal disorders Diarrhea	6.2% 6/97 • 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. 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.	6.2% 6/97 • 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. 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.
General disorders Pyrexia	5.2% 5/97 • 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. 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.	3.1% 3/97 • 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. 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.
Infections and infestations Ear infection	2.8% 3/107 • 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. 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.	5.6% 6/107 • 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. 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.

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