Trial Outcomes & Findings for Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants (NCT NCT00289185)

Last Updated: 2020-10-29

Results Overview

Concentrations were expressed as geometric mean concentrations (GMCs) in milli-international unit per milliliter (mIU/mL). The cut-off of the assay was the seroprotection cut-off of 10 mIU/mL. Month 3 results are the specific results for this primary outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

340 participants

Primary outcome timeframe

Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.

Results posted on

2020-10-29

Participant Flow

A total of 340 subjects were enrolled for this study. The study comprised 2 phases, a double-blind phase, from Week 0 to Month 9 (2 months after the administration of the last vaccine dose), followed by a single-blind safety phase, from Month 9 to study end at Month 20.

Participant milestones

Participant milestones
Measure	Engerix-B Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Study STARTED	170	170
Overall Study COMPLETED	142	144
Overall Study NOT COMPLETED	28	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Engerix-B Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Overall Study Withdrawal by Subject	4	8
Overall Study Lost to Follow-up	23	17
Overall Study Death	1	1

Baseline Characteristics

Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	Total n=340 Participants Total of all reporting groups
Age, Continuous	7.87 Weeks STANDARD_DEVIATION 0.83 • n=5 Participants	7.82 Weeks STANDARD_DEVIATION 0.77 • n=7 Participants	7.85 Weeks STANDARD_DEVIATION 0.80 • n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants	91 Participants n=7 Participants	176 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	79 Participants n=7 Participants	164 Participants n=5 Participants

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.

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.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=148 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=149 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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=134;116)	13.0 milli-international unit per milliliter Interval 9.8 to 17.2	14.3 milli-international unit per milliliter Interval 10.8 to 19.0
Concentrations of Antibodies Against Hepatitis B (Anti-HB) Anti-HB - Month 2 (N=148;149)	16.9 milli-international unit per milliliter Interval 13.5 to 21.2	111.8 milli-international unit per milliliter Interval 89.9 to 139.0
Concentrations of Antibodies Against Hepatitis B (Anti-HB) Anti-HB - Month 3 (N=141;141)	113.8 milli-international unit per milliliter Interval 91.3 to 141.8	667.4 milli-international unit per milliliter Interval 533.8 to 834.4

PRIMARY outcome

Timeframe: From Week 0 to Month 9.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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)	42 Subject	31 Subject

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

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 cut-off of the assay was the seroprotection cut-off of 0.1 IU/mL. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Concentrations of Antibodies Against Diphtheria (Anti-D) Anti-D - PRE (N=165;162)	NA international unit per milliliter GMC for this time point was not computed as concentrations fell below the seroprotection cut-off of 0.1 IU/mL.	NA international unit per milliliter GMC for this time point was not computed as concentrations fell below the seroprotection cut-off of 0.1 IU/mL
Concentrations of Antibodies Against Diphtheria (Anti-D) Anti-D - Month 3 (N=151;149)	1.3 international unit per milliliter Interval 1.1 to 1.5	1.1 international unit per milliliter Interval 1.0 to 1.3

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Concentrations of Antibodies Against Tetanus (Anti-T) Anti-T - PRE (N=165;162)	1.1 international unit per milliliter Interval 0.9 to 1.4	1.2 international unit per milliliter Interval 1.0 to 1.6
Concentrations of Antibodies Against Tetanus (Anti-T) Anti-T - Month 3 (N=151;149)	4.2 international unit per milliliter Interval 3.6 to 4.8	3.0 international unit per milliliter Interval 2.6 to 3.4

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The cut-off of the assay is the seroprotection cut-off value of 0.15 µg/mL. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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). Anti-PRP - PRE (N=165;162)	0.2 international unit per milliliter Interval 0.2 to 0.2	0.2 international unit per milliliter Interval 0.2 to 0.2
Concentrations of Anti-polyribosyl Ribitol Phosphate Antibodies (Anti-PRP). Anti-PRP - Month 3 (N=151;148)	19.3 international unit per milliliter Interval 15.6 to 24.0	14.3 international unit per milliliter Interval 11.5 to 17.9

PRIMARY outcome

Timeframe: From Month 9 to Month 20.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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)	34 Subject	34 Subject

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

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 cut-off of the assay was the seropositivity cut-off of 15 EL.U/mL. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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). Anti-BPT - PRE (N=165;162)	7.6 ELISA unit per millilite Interval 7.4 to 7.8	7.6 ELISA unit per millilite Interval 7.4 to 7.7
Concentrations of Anti-Bordetella Pertussis Toxin Antibodies (Anti-BPT). Anti-BPT - Month 3 (N=144;148)	101.4 ELISA unit per millilite Interval 92.5 to 111.2	82.3 ELISA unit per millilite Interval 75.4 to 89.9

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3.

The seroprotection cut-off value was 10 milli-international units per milliliter (mIU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), at Month 2 and at Month 3. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=148 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=149 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-HB >= 10 mIU/mL - PRE (N=134;116)	45 Subject	44 Subject
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-HB >= 10 mIU/mL - Month 2 (N=148;149)	82 Subject	141 Subject
Number of Subjects With Hepatitis B Antibody (Anti-HB) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-HB >= 10 mIU/mL - Month 3 (N=141;141)	133 Subject	141 Subject

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.1 international unit per milliliter (IU/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-D >= 0.1 IU/mL - PRE (N=165;162)	27 Subject	24 Subject
Number of Subjects With Anti-diphtheria Antibody (Anti-D) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-D >= 0.1 IU/mL - Month 3 (N=151;149)	148 Subject	148 Subject

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-T >= 0.1 IU/mL - PRE (N=165;162)	156 Subject	155 Subject
Number of Subjects With Anti-tetanus Antibody (Anti-T) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-T >= 0.1 IU/mL - Month 3 (N=151;149)	151 Subject	149 Subject

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seroprotection cut-off value was 0.15 microgram per milliliter (µg/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-PRP >= 0.15 µg/mL - PRE (N=165;162)	86 Subjects	78 Subjects
Number of Subjects With Anti-polyribosyl Ribitol Phosphate Antibody (Anti-PRP) Concentrations Equal to or Above (>=) the Seroprotection Cut-off Value Anti-PRP >= 0.15 µg/mL - Month 3 (N=151;148)	150 Subjects	147 Subjects

PRIMARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), and at Month 3.

Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). The seropositivity cut-off value was 15 ELISA units per milliliter (EL.U/mL). Blood samples were collected prior to vaccination at Week 0 (PRE), and at Month 3. Month 3 results are the specific results for this primary outcome measure.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=165 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=162 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value Anti-BPT >= 15 EL.U/mL - PRE (N=165;162)	2 Subjects	1 Subjects
Number of Subjects With Anti-Bordetella Pertussis Toxin Antibody (Anti-BPT) Concentrations Equal to or Above (>=) the Seropositivity Cut-off Value Anti-BPT >= 15 EL.U/mL - Month 3 (N=144;148)	142 Subjects	148 Subjects

SECONDARY outcome

Timeframe: Prior to vaccination at Week 0 (PRE), at Month 2, at Month 3 and at Month 9.

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 cut-off of the assay was the seropositivity cut-off value of 0.5 EL.U/mL.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=156 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=151 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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=152;141)	NA ELISA unit per milliliter GMC was not computed as concentrations fell below the seropositivity cut-off of 0.5 EL.U/mL	NA ELISA unit per milliliter GMC was not computed as concentrations fell below the seropositivity cut-off of 0.5 EL.U/mL
Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies Anti-CS - Month 2 (N=156;151)	NA ELISA unit per milliliter GMC was not computed as concentrations fell below the seropositivity cut-off of 0.5 EL.U/mL	28.9 ELISA unit per milliliter Interval 22.4 to 37.3
Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies Anti-CS - Month 3 (N=144;143)	NA ELISA unit per milliliter GMC was not computed as concentrations fell below the seropositivity cut-off of 0.5 EL.U/mL	69.5 ELISA unit per milliliter Interval 53.9 to 89.6
Concentrations of Anti-Circumsporozoite Protein (Anti-CS) Antibodies Anti-CS - Month 9 (N=147;143)	NA ELISA unit per milliliter GMC was not computed as concentrations fell below the seropositivity cut-off of 0.5 EL.U/mL	6.2 ELISA unit per milliliter Interval 4.6 to 8.3

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after vaccination with the RTS,S/AS02D or Engerix-B vaccine.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Assessed solicited local symptoms were pain and swelling following vaccination with the RTS,S/AS02D or Engerix-B vaccine.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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	167 Subject	161 Subject
Number of Subjects With Solicited Local Symptoms. Swelling	17 Subject	19 Subject

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after vaccination with the TETRActHib vaccine.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Assessed solicited local symptoms were pain and swelling following vaccination with the TETRActHib vaccine..

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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	169 Subject	168 Subject
Number of Subjects With Solicited Local Symptoms. Swelling	68 Subject	67 Subject

SECONDARY outcome

Timeframe: Within 7 days (Days 0-6) after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Assessed solicited general symptoms were drowsiness, fever, irritability, and loss of appetite. Fever was defined as axillary temperature above or equal to (\>=) 37.5 degrees Celsius (°C).

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects With Solicited General Symptoms. Drowsiness	4 Subject	3 Subject
Number of Subjects With Solicited General Symptoms. Fever (Temperature ≥ 37.5°C)	52 Subject	103 Subject
Number of Subjects With Solicited General Symptoms. Irritability	71 Subject	81 Subject
Number of Subjects With Solicited General Symptoms. Loss of Appetite	5 Subject	5 Subject

SECONDARY outcome

Timeframe: Within 30 days (Days 0-29) after vaccination

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

An unsolicited adverse event is any adverse event (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

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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).	141 Subjects	137 Subjects

SECONDARY outcome

Timeframe: Throughout the entire study, from Week 0 to Month 20.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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)	62 Subjects	57 Subjects

SECONDARY outcome

Timeframe: Over the period starting 14 days after Dose 3 of RTS,S or HBV vaccine and extending for 6 months thereafter (from Month 2.5 up to Month 9).

Population: The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects 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

Outcome measures
Measure	Engerix-B Group n=151 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=146 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Time to First Malaria Infection	0.29 n/PYAR	0.12 n/PYAR

SECONDARY outcome

Timeframe: At Month 9

Population: The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects 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

Outcome measures
Measure	Engerix-B Group n=92 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=93 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
Number of Subjects Prevalent for Parasitemia	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: At Month 9

Population: The analysis was performed on the According-to-Protocol cohort for efficacy, which included all evaluable subjects 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 7 months after administration of Dose 3 of RTS,S or HBV vaccine (Month 9). Parasite density is expressed as mean, minimum and maximum density in parasite per µL. This outcome for solely assessed in the Engerix-B Group, as no subject in the RTS,S/AS02D was assessed as prevalent for parasitemia.

Outcome measures

Outcome measures
Measure	Engerix-B Group n=1 Participants Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D 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	23276 Parasite per microliter (µL) Interval 23276.0 to 23276.0	—

Adverse Events

Engerix-B Group

Serious events: 62 serious events

Other events: 169 other events

Deaths: 0 deaths

RTS,S/AS02D Group

Serious events: 57 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Engerix-B Group n=170 participants at risk Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 participants at risk Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
General disorders Pain	99.4% 169/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	98.8% 168/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
General disorders Swelling	40.0% 68/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	39.4% 67/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
General disorders Fever	30.6% 52/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	60.6% 103/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
General disorders Irritability	41.8% 71/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	47.6% 81/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Eye disorders Conjunctivitis	3.5% 6/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	7.1% 12/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Acarodermatitis	2.4% 4/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	7.6% 13/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Pneumonia	31.8% 54/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	28.8% 49/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Skin infection	1.8% 3/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	6.5% 11/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Cough	47.1% 80/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	47.1% 80/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	42.9% 73/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	32.9% 56/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Skin and subcutaneous tissue disorders Rash	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	7.1% 12/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Engerix-B Group n=170 participants at risk Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.	RTS,S/AS02D Group n=170 participants at risk Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
Blood and lymphatic system disorders Anaemia	9.4% 16/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	9.4% 16/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.8% 3/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
General disorders Pyrexia	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Abscess	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Abscess limb	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Abscess neck	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Acarodermatitis	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Bronchiolitis	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Cellulitis	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Cerebral malaria	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Dysentery	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Gastroenteritis	7.1% 12/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	9.4% 16/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Malaria	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Measles	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Meningitis viral	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Plasmodium falciparum infection	14.7% 25/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	11.2% 19/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Pneumonia	21.2% 36/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	14.7% 25/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Pneumonia viral	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Pyoderma	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Sepsis	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Upper respiratory tract infection	1.8% 3/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Urinary tract infection	1.8% 3/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	2.4% 4/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Infections and infestations Viral infection	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Injury, poisoning and procedural complications Poisoning	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Injury, poisoning and procedural complications Thermal burn	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Nervous system disorders Convulsion	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Nervous system disorders Febrile convulsion	1.2% 2/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	2.9% 5/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	1.8% 3/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Loeffler's syndrome	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.
Respiratory, thoracic and mediastinal disorders Pulmonary pneumatocele	0.00% 0/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.	0.59% 1/170 • Time frames for adverse events (AEs) reporting were the 7-day (Days 0-6) and 21-day (Days 0-20) periods post vaccination for solicited symptoms and unsolicited AES, respectively. Serious adverse events were assessed throughout, from Week 0 to Month 20.