Trial Outcomes & Findings for Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults. (NCT NCT00197054)

NCT ID: NCT00197054

Last Updated: 2021-02-12

Results Overview

Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 255 participants
• Primary outcome timeframe: 7 day follow-up (day of vaccination + 6 days)
• Results posted on: 2021-02-12

Participant Flow

255 subjects were enrolled and randomized 1:1:1 into each arm at Kombewa Clinic, US Army Medical Research Unit, Kisumu Kenya.

Participant milestones

Measure	RTS, S/AS02A RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Overall Study STARTED	85	85	85
Overall Study COMPLETED	68	64	73
Overall Study NOT COMPLETED	17	21	12

Reasons for withdrawal

Measure	RTS, S/AS02A RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Overall Study Withdrawal by Subject	9	3	3
Overall Study Moved from area	7	14	9
Overall Study Lost to Follow-up	1	4	0

Baseline Characteristics

Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

Baseline characteristics by cohort

Measure	RTS, S/AS02A n=85 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=85 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months	Total n=255 Participants Total of all reporting groups
Age, Continuous	25.2 years STANDARD_DEVIATION 5.16 • n=93 Participants	24.9 years STANDARD_DEVIATION 5.50 • n=4 Participants	26.1 years STANDARD_DEVIATION 5.10 • n=27 Participants	25.4 years STANDARD_DEVIATION 5.26 • n=483 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	21 Participants n=4 Participants	12 Participants n=27 Participants	52 Participants n=483 Participants
Sex: Female, Male Male	66 Participants n=93 Participants	64 Participants n=4 Participants	73 Participants n=27 Participants	203 Participants n=483 Participants
Region of Enrollment Kenya	85 participants n=93 Participants	85 participants n=4 Participants	85 participants n=27 Participants	255 participants n=483 Participants

PRIMARY outcome

Timeframe: 7 day follow-up (day of vaccination + 6 days)

Population: Rabipur was a comparator vaccine and not relevant to results of this primary outcome. Results for Rabipur were not presented in data table.

Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days).

Outcome measures

Measure	RTS, S/AS02A n=85 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=85 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B	0 participants Interval 0.0 to 4.2	1 participants Interval 0.0 to 6.4	—

PRIMARY outcome

Timeframe: 6.5 months

Grade 3 unsolicited symptoms reported following any number of administered doses

Outcome measures

Measure	RTS, S/AS02A n=242 Doses RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=247 Doses RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=247 Doses Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms At least one symptom	3 administered doses Interval 0.3 to 3.6	0 administered doses Interval 0.0 to 1.5	1 administered doses Interval 0.0 to 2.2
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms Sinusitis	1 administered doses Interval 0.0 to 2.3	0 administered doses Interval 0.0 to 1.5	0 administered doses Interval 0.0 to 1.5
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms Headache	1 administered doses Interval 0.0 to 2.3	0 administered doses Interval 0.0 to 1.5	1 administered doses Interval 0.0 to 2.2
Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms Cough	1 administered doses Interval 0.0 to 2.3	0 administered doses Interval 0.0 to 1.5	0 administered doses Interval 0.0 to 1.5

PRIMARY outcome

Timeframe: 7 day follow-up period (day of vaccination + 6 days)

Population: number of administered doses

Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort)

Outcome measures

Measure	RTS, S/AS02A n=242 Doses RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=247 Doses RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=247 Doses Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Pain	132 Doses	166 Doses	68 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Swelling	12 Doses	22 Doses	2 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Fatigue	43 Doses	33 Doses	35 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Fever (Axillary)	21 Doses	14 Doses	12 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Gastrointestinal	48 Doses	42 Doses	44 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Headache	84 Doses	95 Doses	67 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Joint pain at other location	27 Doses	22 Doses	22 Doses
Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period Muscle aches	27 Doses	23 Doses	29 Doses

SECONDARY outcome

Timeframe: months 6.5 thru 12

Population: Number of subjects with at least one administered dose

Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12)

Outcome measures

Measure	RTS, S/AS02A n=74 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=76 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=76 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Safety: Occurrence of SAEs Wound Necrosis	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Abscess Limb	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs HIV Infection	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Lobar Pneumonia	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Abortion	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Haemoptysis	2.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Pleural Effusion	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Anaemia	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Cardiac Failure	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Pericardial Effusion	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Cataract	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Malaria	0.0 % of subjects Interval 0.0 to 4.9	1.3 % of subjects Interval 0.0 to 7.1	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Meningitis	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Pneumonia	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7
Safety: Occurrence of SAEs Pulmonary Tuberculosis	0.0 % of subjects Interval 0.0 to 4.9	0.0 % of subjects Interval 0.0 to 4.7	1.3 % of subjects Interval 0.0 to 7.1
Safety: Occurrence of SAEs Trichomoniasis	1.4 % of subjects Interval 0.0 to 7.3	0.0 % of subjects Interval 0.0 to 4.7	0.0 % of subjects Interval 0.0 to 4.7

SECONDARY outcome

Timeframe: months 0 thru 12

Population: Number of subjects with at least one administered dose

Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12)

Outcome measures

Measure	RTS, S/AS02A n=85 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=85 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Safety: Occurrence of SAEs Anaemia	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Cardiac Failure	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Pericardial Effusion	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Cataract	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Peptic Ulcer Haemorrhage	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Wound Necrosis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Abscess Limb	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Disseminated Tuberculosis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs HIV Infection	2.4 % of subjects reporting symptom Interval 0.3 to 8.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	3.5 % of subjects reporting symptom Interval 0.7 to 10.0
Safety: Occurrence of SAEs Lobar Pneumonia	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Malaria	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Meningitis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Meningitis Cryptococcal	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Pneumocystis Jiroveci Pheumonia	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Pneumonia	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Abortion	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Haemoptysis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Pleural Effusion	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Pulmonary Tuberculosis	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	1.2 % of subjects reporting symptom Interval 0.0 to 6.4
Safety: Occurrence of SAEs Trichomoniasis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Osteoarthritis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2
Safety: Occurrence of SAEs Encephalitis	1.2 % of subjects reporting symptom Interval 0.0 to 6.4	0.0 % of subjects reporting symptom Interval 0.0 to 4.2	0.0 % of subjects reporting symptom Interval 0.0 to 4.2

SECONDARY outcome

Timeframe: Days 0, 6, 66, and 90; Months 6 and 12

Occurrence of hematology parameters below normal range (Total Cohort)

Outcome measures

Measure	RTS, S/AS02A n=85 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=85 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Occurrence of Hematology Parameters Below Normal Range Hemoglobin: Day 0	0 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Hemoglobin: Day 6	4 Participants	1 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range Hemoglobin: Day 66	2 Participants	1 Participants	2 Participants
Occurrence of Hematology Parameters Below Normal Range Hemoglobin: Day 90	2 Participants	0 Participants	2 Participants
Occurrence of Hematology Parameters Below Normal Range hemoglobin: Month 6	2 Participants	1 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range Hemoglobin: Month 12	4 Participants	2 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Day 0	0 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Day 6	0 Participants	0 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Day 66	0 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Day 90	1 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Month 6	1 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range Lymphocytes: Month 12	1 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Day 0	0 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Day 6	0 Participants	0 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Day 66	0 Participants	0 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Day 90	3 Participants	0 Participants	0 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Month 6	2 Participants	0 Participants	1 Participants
Occurrence of Hematology Parameters Below Normal Range WBC: Month 12	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 0, 6, and 90

Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort)

Outcome measures

Measure	RTS, S/AS02A n=85 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=85 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Occurrence of Biochemistry Parameters Above Normal Ranges Bilirubin: Day 0	10 Participants	9 Participants	11 Participants
Occurrence of Biochemistry Parameters Above Normal Ranges Bilirubin: Day 6	6 Participants	4 Participants	7 Participants
Occurrence of Biochemistry Parameters Above Normal Ranges Bilirubin: Day 90	3 Participants	3 Participants	6 Participants
Occurrence of Biochemistry Parameters Above Normal Ranges ALT: Day 0	0 Participants	0 Participants	0 Participants
Occurrence of Biochemistry Parameters Above Normal Ranges ALT: Day 6	1 Participants	6 Participants	0 Participants
Occurrence of Biochemistry Parameters Above Normal Ranges ALT: Day 90	0 Participants	1 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination

Outcome measures

Measure	RTS, S/AS02A n=163 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=163 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE % of Non-infected	38.8 percentage of participants Interval 27.1 to 51.5	37.3 percentage of participants Interval 25.8 to 50.0	—
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE % of Infected	50.0 percentage of participants Interval 39.6 to 60.4	44.8 percentage of participants Interval 34.6 to 55.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=152 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=152 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) % of Non-infected: PIII(D90)	96.5 percentage of participants Interval 87.9 to 99.6	93.0 percentage of participants Interval 83.0 to 98.1	—
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) % of Infected: PIII(D90)	93.7 percentage of participants Interval 86.8 to 97.6	91.6 percentage of participants Interval 84.1 to 96.3	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)

Outcome measures

Measure	RTS, S/AS02A n=132 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=132 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) % of Non-infected: PIII(M12)	97.9 percentage of participants Interval 88.7 to 99.9	91.5 percentage of participants Interval 79.6 to 97.6	—
Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) % of Infected: PIII(M12)	92.9 percentage of participants Interval 85.3 to 97.4	90.6 percentage of participants Interval 82.3 to 95.8	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: Subject with available results

Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seropositive >3.3 mlU/ML

PRE=Prevaccination

Outcome measures

Measure	RTS, S/AS02A n=73 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=70 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=68 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE	31 Participants	38 Participants	35 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: Subjects with available results

Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seropositive >3.3 mlU/ML

PIII(D90)= post dose 3 (Day 90)

Outcome measures

Measure	RTS, S/AS02A n=72 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=72 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=65 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90)	68 Participants	68 Participants	37 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: Subjects with available results

Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seropositive >3.3 mlU/ML

PIII(M12)= post dose 3 (Month 12)

Outcome measures

Measure	RTS, S/AS02A n=61 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=62 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=66 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12)	57 Participants	59 Participants	40 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: Subjects with available results

Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seroprotected >10 mlU/mL

PRE=Prevaccination

Outcome measures

Measure	RTS, S/AS02A n=73 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=70 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=68 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE	29 Participants	34 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: Subject with available results

Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seroprotected >10 mlU/mL

PIII(D90)= post dose 3 (Day 90)

Outcome measures

Measure	RTS, S/AS02A n=72 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=72 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=65 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90)	65 Participants	67 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: Subjects with available results

Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity).

Seroprotected >10 mlU/mL

PIII(M12)= post dose 3 (Month 12)

Outcome measures

Measure	RTS, S/AS02A n=61 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=62 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=66 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12)	55 Participants	57 Participants	33 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: Subjects with available results

Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity)

PRE=Prevaccination

Outcome measures

Measure	RTS, S/AS02A n=73 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=70 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=68 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE	11.1 titers Interval 6.0 to 20.4	18.3 titers Interval 9.4 to 35.3	23.6 titers Interval 11.3 to 49.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: Subjects with available results

Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity)

PIII(D90)= post dose 3 (Day 90)

Outcome measures

Measure	RTS, S/AS02A n=72 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=72 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=65 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90)	1434.9 titers Interval 743.0 to 2770.9	1714.3 titers Interval 836.1 to 3515.0	31.7 titers Interval 14.6 to 68.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: Subjects with available results

Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity)

PIII(M12)= post dose 3 (Month 12)

Outcome measures

Measure	RTS, S/AS02A n=61 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=62 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=66 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12)	593.7 titers Interval 317.0 to 1111.9	635.8 titers Interval 341.9 to 1182.5	28.6 titers Interval 13.8 to 59.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination

Outcome measures

Measure	RTS, S/AS02A n=163 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE Non-infected: PRE	11.1 titer Interval 5.7 to 21.6	—	—
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE Infected: PRE	13.5 titer Interval 7.9 to 22.9	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 90

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=152 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) Non-infected: PIII(D90)	1558.3 titer Interval 744.7 to 3260.7	—	—
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) Infected: PIII(D90)	1532.6 titer Interval 844.2 to 2782.4	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 12

Population: The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12)

Outcome measures

Measure	RTS, S/AS02A n=132 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) Non-infected: PIII(M12)	765.8 titer Interval 384.8 to 1524.3	—	—
Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) Infected: PIII(M12)	499.0 titer Interval 293.1 to 849.5	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination

Outcome measures

Measure	RTS, S/AS02A n=75 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=74 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=73 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE	2.2 titers Interval 1.6 to 2.9	1.2 titers Interval 0.9 to 1.6	1.9 titers Interval 1.4 to 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post dose 2

Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60)

Outcome measures

Measure	RTS, S/AS02A n=75 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=74 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=73 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60)	31.6 titers Interval 23.9 to 41.6	16.7 titers Interval 12.9 to 21.7	1.8 titers Interval 1.4 to 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)

Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=72 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=72 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=69 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90)	41.4 titers Interval 31.7 to 54.2	21.4 titers Interval 16.0 to 28.7	1.1 titers Interval 1.1 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)

Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5)

Outcome measures

Measure	RTS, S/AS02A n=69 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=69 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=69 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5)	23.1 titers Interval 17.1 to 31.1	13.1 titers Interval 9.7 to 17.7	1.5 titers Interval 1.1 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 months post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)

Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12)

Outcome measures

Measure	RTS, S/AS02A n=61 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=62 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=66 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12)	14.2 titers Interval 10.7 to 18.9	7.3 titers Interval 5.2 to 10.2	1.7 titers Interval 1.3 to 2.3

OTHER_PRE_SPECIFIED outcome

Timeframe: PRE

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination

Outcome measures

Measure	RTS, S/AS02A n=153 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE Non-infected: PRE	2.0 titers Interval 1.6 to 2.6	—	—
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE Infected: PRE	1.2 titers Interval 0.9 to 1.7	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 2 (day 60)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)

Outcome measures

Measure	RTS, S/AS02A n=153 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) Infected: PII(D60)	11.9 titers Interval 8.4 to 17.0	—	—
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) Non-infected: PII(D60)	33.9 titers Interval 28.1 to 40.9	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 3 (day 90)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=151 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) Infected: PIII(D90)	18.3 titers Interval 12.7 to 26.5	—	—
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) Non-infected: PIII(D90)	40.1 titers Interval 32.6 to 49.2	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 3 (month 6.5)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined.

Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)

Outcome measures

Measure	RTS, S/AS02A n=143 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) Infected: PIII(M6.5)	9.9 titers Interval 6.7 to 14.6	—	—
Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) Non-infected: PIII(M6.5)	25.1 titers Interval 20.3 to 31.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: Immunogenicity (ATP Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3

PRE= prevaccination

Outcome measures

Measure	RTS, S/AS02A n=75 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=74 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=73 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE	86.7 percentage of participants Interval 76.8 to 93.4	75.7 percentage of participants Interval 64.3 to 84.9	84.9 percentage of participants Interval 74.6 to 92.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post dose 2

Population: Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine)

Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3.

PII(D60)= post dose 2 (day 60)

Outcome measures

Measure	RTS, S/AS02A n=75 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=74 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=73 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60)	98.7 percentage of participants Interval 92.8 to 100.0	100 percentage of participants Interval 95.1 to 100.0	84.9 percentage of participants Interval 74.6 to 92.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine)

Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3

PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=72 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=72 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=69 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90)	98.6 percentage of participants Interval 92.5 to 100.0	100 percentage of participants Interval 95.0 to 100.0	82.6 percentage of participants Interval 71.6 to 90.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 months post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine)

Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3

PIII(M6.5)= post dose 3 (month 6.5)

Outcome measures

Measure	RTS, S/AS02A n=69 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=69 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=69 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5)	98.6 percentage of participants Interval 92.2 to 100.0	98.6 percentage of participants Interval 92.2 to 100.0	79.7 percentage of participants Interval 68.3 to 88.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 months post dose 3

Population: Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine)

Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3

PIII(M12)= post dose 3 (month 12)

Outcome measures

Measure	RTS, S/AS02A n=61 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=62 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=66 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12)	100 percentage of participants Interval 94.1 to 100.0	95.2 percentage of participants Interval 86.5 to 99.0	80.3 percentage of participants Interval 68.7 to 89.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination

Outcome measures

Measure	RTS, S/AS02A n=153 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE % of Non-infected: PRE	83.5 percentage of participants Interval 74.6 to 90.3	—	—
Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE % of Infected: PRE	76.8 percentage of participants Interval 63.6 to 87.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 2 (day 60)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60)

Outcome measures

Measure	RTS, S/AS02A n=153 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) % of Infected: PII(D60)	98.2 percentage of participants Interval 90.4 to 100.0	—	—
Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) % of Non-infected: PII(D60)	100 percentage of participants Interval 96.3 to 100.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 3 (day 90)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90)

Outcome measures

Measure	RTS, S/AS02A n=151 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) % of Infected: PIII(D90)	98.2 percentage of participants Interval 90.4 to 100.0	—	—
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) % of Non-infected: PIII(D90)	100 percentage of participants Interval 96.2 to 100.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: post dose 3 (month 6.5)

Population: The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined.

Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5)

Outcome measures

Measure	RTS, S/AS02A n=143 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) % of Infected: PIII(M6.5)	98.1 percentage of participants Interval 90.1 to 100.0	—	—
Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) % of Non-infected: PIII(M6.5)	98.9 percentage of participants Interval 93.9 to 100.0	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days after dose 3 and extending for 14 weeks

Population: Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).

Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection)

Outcome measures

Measure	RTS, S/AS02A n=74 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=79 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=75 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Efficacy: Vaccine Efficacy Against P. Falciparum Infection	28 participants	28 participants	37 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: at month 6.5

Population: Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine). Missing subject data: S/AS01B = 4, S/AS02A = 6, Rabipur = 4

Percentage of participants with positive and negative parasite density at month 6.5

Outcome measures

Measure	RTS, S/AS02A n=74 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=79 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=75 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Percentage of Participants With Positive and Negative Parasite Density Parasite Density: % of Negative Subjects	91.4 % of subjects	93.2 % of subjects	95.8 % of subjects
Percentage of Participants With Positive and Negative Parasite Density Parasite Density: % of Positive Subjects	8.6 % of subjects	6.8 % of subjects	4.2 % of subjects

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6.5

Population: Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine).

Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5

Outcome measures

Measure	RTS, S/AS02A n=74 Participants RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	RTS, S/AS01B n=79 Participants RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=75 Participants Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia	1122 titers Interval -525.0 to 2769.0	342 titers Interval -115.4 to 799.8	711 titers Interval -846.8 to 2268.8

Adverse Events

(RTS, S/AS01B)

Serious events: 5 serious events

Other events: 81 other events

Deaths: 0 deaths

(RTS, S/AS02A)

Serious events: 1 serious events

Other events: 82 other events

Deaths: 0 deaths

Rabipur (Rabies) Vaccine

Serious events: 5 serious events

Other events: 82 other events

Deaths: 0 deaths

Serious adverse events

Measure	(RTS, S/AS01B) n=85 participants at risk RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	(RTS, S/AS02A) n=85 participants at risk RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 participants at risk Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months Rabipur (Rabies) Vaccine: .0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Blood and lymphatic system disorders Anaemia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Cardiac disorders Cardiac failure	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Cardiac disorders Pericardial effusion	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Eye disorders Cataract	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
General disorders Wound necrosis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Abscess limb	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations HIV infection	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Infections and infestations Lobar pneumonia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Malaria	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Meningitis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Pneumonia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Pulmonary tuberculosis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Trichomoniasis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Pregnancy, puerperium and perinatal conditions Abortion	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Peptic Ulcer	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Disseminated tuberculosis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Meningitis cryptococcal	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Pneumocystis jiroveci pneumonia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Metabolism and nutrition disorders Osteoarthritis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Nervous system disorders Encephalitis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months

Other adverse events

Measure	(RTS, S/AS01B) n=85 participants at risk RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	(RTS, S/AS02A) n=85 participants at risk RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.	Rabipur (Rabies) Vaccine n=85 participants at risk Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months Rabipur (Rabies) Vaccine: .0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Renal and urinary disorders Dysuria	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Reproductive system and breast disorders Balanitis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Rash pruritis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Skin and subcutaneous tissue disorders Swelling face	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Reproductive system and breast disorders Genital ulceration	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Reproductive system and breast disorders Mammory duct ectasia	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Cough epistaxis	17.6% 15/85 • Number of events 15 • 12 months	12.9% 11/85 • Number of events 11 • 12 months	11.8% 10/85 • Number of events 10 • 12 months
Respiratory, thoracic and mediastinal disorders Epixtaxis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	7.1% 6/85 • Number of events 6 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	11.8% 10/85 • Number of events 10 • 12 months
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Respiratory, thoracic and mediastinal disorders Rhonchi	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Skin and subcutaneous tissue disorders Acne	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Skin and subcutaneous tissue disorders Dermatitis allergic	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Skin and subcutaneous tissue disorders Eczema	3.5% 3/85 • Number of events 3 • 12 months	5.9% 5/85 • Number of events 5 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Night sweats	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Skin and subcutaneous tissue disorders Pruritus	4.7% 4/85 • Number of events 4 • 12 months	11.8% 10/85 • Number of events 10 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Skin and subcutaneous tissue disorders Pruritus generalised	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
General disorders Fatigue	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
General disorders Fever	20.0% 17/85 • Number of events 17 • 12 months	12.9% 11/85 • Number of events 11 • 12 months	11.8% 10/85 • Number of events 10 • 12 months
Gastrointestinal disorders Gastrointestinal	43.5% 37/85 • Number of events 37 • 12 months	38.8% 33/85 • Number of events 33 • 12 months	38.8% 33/85 • Number of events 33 • 12 months
Nervous system disorders Headache	28.2% 24/85 • Number of events 24 • 12 months	37.6% 32/85 • Number of events 32 • 12 months	43.5% 37/85 • Number of events 37 • 12 months
Musculoskeletal and connective tissue disorders Joint pain at other location	27.1% 23/85 • Number of events 23 • 12 months	22.4% 19/85 • Number of events 19 • 12 months	20.0% 17/85 • Number of events 17 • 12 months
Musculoskeletal and connective tissue disorders Muscle aches	24.7% 21/85 • Number of events 21 • 12 months	24.7% 21/85 • Number of events 21 • 12 months	28.2% 24/85 • Number of events 24 • 12 months
Blood and lymphatic system disorders Anaemia	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Blood and lymphatic system disorders Eosinophilia	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Cardiac disorders Palpitations	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Ear and labyrinth disorders Cerumen impaction	2.4% 2/85 • Number of events 2 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	7.1% 6/85 • Number of events 6 • 12 months
Ear and labyrinth disorders Ear pain	7.1% 6/85 • Number of events 6 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Eye disorders Conjunctivitis	11.8% 10/85 • Number of events 10 • 12 months	10.6% 9/85 • Number of events 9 • 12 months	9.4% 8/85 • Number of events 8 • 12 months
Eye disorders Conjunctivitis allergic	7.1% 6/85 • Number of events 6 • 12 months	10.6% 9/85 • Number of events 9 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Eye disorders Eye pain	0.00% 0/85 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Gastrointestinal disorders Abdominal discomfort	2.4% 2/85 • Number of events 2 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Gastrointestinal disorders Abdominal distension	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Gastrointestinal disorders Abdominal pain	5.9% 5/85 • Number of events 5 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Gastrointestinal disorders Anal skin tags	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Anal ulcer	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Aphthous stomatitis	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Bowel sounds	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Constipation	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Diarrhea	3.5% 3/85 • Number of events 3 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	7.1% 6/85 • Number of events 6 • 12 months
Gastrointestinal disorders Diarrhea haemorrhagic	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Dyspepsia	5.9% 5/85 • Number of events 5 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Enteritis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Flatulence	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Gastritis	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Gingival pain	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Gingivitis	4.7% 4/85 • Number of events 4 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Gastrointestinal disorders Glossitis	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Glossodynia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Hyperchlorhydria	4.7% 4/85 • Number of events 4 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Gastrointestinal disorders Lip exfoliation	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Mouth ulceration	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Nausea	1.2% 1/85 • Number of events 1 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Gastrointestinal disorders Oesophagitis	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Gastrointestinal disorders Peptic ulcer	3.5% 3/85 • Number of events 3 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Gastrointestinal disorders Peptic ulcer haemorrhage	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Proctalgia	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Stomatitis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Gastrointestinal disorders Toothache	16.5% 14/85 • Number of events 14 • 12 months	10.6% 9/85 • Number of events 9 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Gastrointestinal disorders Vomiting	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
General disorders Asthenia	3.5% 3/85 • Number of events 3 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
General disorders Chest pain	10.6% 9/85 • Number of events 9 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	14.1% 12/85 • Number of events 12 • 12 months
General disorders Chills	7.1% 6/85 • Number of events 6 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
General disorders Feeling hot	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
General disorders Hangover	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
General disorders Hunger	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
General disorders Inflammation	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
General disorders Malaise	8.2% 7/85 • Number of events 7 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
General disorders Nodule	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
General disorders Pain	9.4% 8/85 • Number of events 8 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
General disorders Pitting oedema	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
General disorders Pyrexia	17.6% 15/85 • Number of events 15 • 12 months	14.1% 12/85 • Number of events 12 • 12 months	12.9% 11/85 • Number of events 11 • 12 months
General disorders Swelling	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
General disorders Thirst	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Immune system disorders Hypersensitivity	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Immune system disorders Multiple allergies	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Abscess	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Abscess limb	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Acarodermatitis	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Amoebiasis	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Ascariasis	1.2% 1/85 • Number of events 1 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Body tinea	7.1% 6/85 • Number of events 6 • 12 months	7.1% 6/85 • Number of events 6 • 12 months	5.9% 5/85 • Number of events 5 • 12 months
Infections and infestations Bronchitis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Candidiasis	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Cellulitis	3.5% 3/85 • Number of events 3 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Infections and infestations Conjunctivitis infective	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Dental caries	8.2% 7/85 • Number of events 7 • 12 months	5.9% 5/85 • Number of events 5 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Infections and infestations Dysentery	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Infections and infestations Folliculitis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Fungal infection	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Furuncle	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Infections and infestations Gastroenteritis	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	7.1% 6/85 • Number of events 6 • 12 months
Infections and infestations Gastroenteritis bacterial	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Genitourinary tract infection	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Giardiasis	8.2% 7/85 • Number of events 7 • 12 months	12.9% 11/85 • Number of events 11 • 12 months	10.6% 9/85 • Number of events 9 • 12 months
Infections and infestations Gonorrhea	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Helminthic infection	9.4% 8/85 • Number of events 8 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Infections and infestations Herpes simplex	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Hookworm infection	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Hordeolum	0.00% 0/85 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Impetigo	7.1% 6/85 • Number of events 6 • 12 months	8.2% 7/85 • Number of events 7 • 12 months	9.4% 8/85 • Number of events 8 • 12 months
Infections and infestations Laryngitis	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Malaria	22.4% 19/85 • Number of events 19 • 12 months	16.5% 14/85 • Number of events 14 • 12 months	24.7% 21/85 • Number of events 21 • 12 months
Infections and infestations Otitis externa	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Otitis media	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Otitis media acute	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Pelvic inflammatory disease	2.4% 2/85 • Number of events 2 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Pharyngitis	8.2% 7/85 • Number of events 7 • 12 months	5.9% 5/85 • Number of events 5 • 12 months	10.6% 9/85 • Number of events 9 • 12 months
Infections and infestations Pneumonia	5.9% 5/85 • Number of events 5 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Pulpitis dental	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Respiratory tract infection	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Infections and infestations Rhinitis	14.1% 12/85 • Number of events 12 • 12 months	9.4% 8/85 • Number of events 8 • 12 months	10.6% 9/85 • Number of events 9 • 12 months
Infections and infestations Schistosomiasis	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Septic rash	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Sexually transmitted disease	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Sinusitis	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Strongyloidiasis	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Subcutaneous abscess	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Tinea capitis	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Tinea cruris	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Tinea infection	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Tinea pedis	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Tinea versicolour	3.5% 3/85 • Number of events 3 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	4.7% 4/85 • Number of events 4 • 12 months
Infections and infestations Tonsillitis	4.7% 4/85 • Number of events 4 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Tooth abscess	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Trichomoniasis	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Typhoid fever	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Infections and infestations Upper respiratory tract infection	58.8% 50/85 • Number of events 50 • 12 months	63.5% 54/85 • Number of events 54 • 12 months	56.5% 48/85 • Number of events 48 • 12 months
Infections and infestations Urethritis	3.5% 3/85 • Number of events 3 • 12 months	0.00% 0/85 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Infections and infestations Urinary tract infection	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Infections and infestations Vaginal candidiasis	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Vulvovaginitis	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Wound infection	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Infections and infestations Wound sepsis	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Animal bite	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Contusion	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Injury, poisoning and procedural complications Excoriation	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Eye injury	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Injury, poisoning and procedural complications Face injury	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Injury, poisoning and procedural complications Joint sprain	2.4% 2/85 • Number of events 2 • 12 months	2.4% 2/85 • Number of events 2 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Laceration	3.5% 3/85 • Number of events 3 • 12 months	0.00% 0/85 • 12 months	7.1% 6/85 • Number of events 6 • 12 months
Injury, poisoning and procedural complications Neck injury	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Injury, poisoning and procedural complications Procedural pain	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Injury, poisoning and procedural complications Skin laceration	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Soft tissue injury	16.5% 14/85 • Number of events 14 • 12 months	21.2% 18/85 • Number of events 18 • 12 months	23.5% 20/85 • Number of events 20 • 12 months
Injury, poisoning and procedural complications Wound	5.9% 5/85 • Number of events 5 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	5.9% 5/85 • Number of events 5 • 12 months
Investigations Mean cell volume decreased	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Metabolism and nutrition disorders Anorexia	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	2.4% 2/85 • Number of events 2 • 12 months
Metabolism and nutrition disorders Decreased appetite	29.4% 25/85 • Number of events 25 • 12 months	17.6% 15/85 • Number of events 15 • 12 months	22.4% 19/85 • Number of events 19 • 12 months
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Arthralgia	12.9% 11/85 • Number of events 11 • 12 months	5.9% 5/85 • Number of events 5 • 12 months	11.8% 10/85 • Number of events 10 • 12 months
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Back pain	18.8% 16/85 • Number of events 16 • 12 months	15.3% 13/85 • Number of events 13 • 12 months	23.5% 20/85 • Number of events 20 • 12 months
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Musculoskeletal and connective tissue disorders Myalgia	12.9% 11/85 • Number of events 11 • 12 months	10.6% 9/85 • Number of events 9 • 12 months	15.3% 13/85 • Number of events 13 • 12 months
Musculoskeletal and connective tissue disorders Neck pain	8.2% 7/85 • Number of events 7 • 12 months	4.7% 4/85 • Number of events 4 • 12 months	0.00% 0/85 • 12 months
Musculoskeletal and connective tissue disorders Pain in extremity	3.5% 3/85 • Number of events 3 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	3.5% 3/85 • Number of events 3 • 12 months
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Sensation of heaviness	2.4% 2/85 • Number of events 2 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months
Nervous system disorders Dizziness	10.6% 9/85 • Number of events 9 • 12 months	3.5% 3/85 • Number of events 3 • 12 months	5.9% 5/85 • Number of events 5 • 12 months
Nervous system disorders Sinus headache	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months
Nervous system disorders Tension headache	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Psychiatric disorders Alcoholism	1.2% 1/85 • Number of events 1 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months
Psychiatric disorders Insomnia	0.00% 0/85 • 12 months	0.00% 0/85 • 12 months	1.2% 1/85 • Number of events 1 • 12 months

Additional Information

LTC Mark Polhemus MD, MC

Kombewa Clinic, US Army Medical Research Unit, Kisumo Kenya

Phone: 877-379-3788

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

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