Trial Outcomes & Findings for Developing World Study for RotaTeq™ (V260-015)(COMPLETED) (NCT NCT00362648)

NCT ID: NCT00362648

Last Updated: 2017-04-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 7504 participants
• Primary outcome timeframe: At least 14 days following the third vaccination
• Results posted on: 2017-04-13

Participant Flow

The study was conducted at 5 international sites - Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given). Last subject completed follow-up: 31 March 2009 All data corrections applied (Frozen File): 20 July 2009

Excluded from the trial before assignment to groups were subjects: with history of active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.

Participant milestones

Measure	RotaTeq™ - Africa Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Overall Study STARTED	2733	2735	1018	1018
Overall Study Vaccinated at Visit 1	2733	2735	1018	1018
Overall Study Vaccinated at Visit 2	2657	2666	1013	1009
Overall Study Vaccinated at Visit 3	2613	2612	1009	1007
Overall Study COMPLETED	2607	2601	1009	1007
Overall Study NOT COMPLETED	126	134	9	11

Reasons for withdrawal

Measure	RotaTeq™ - Africa Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Overall Study Adverse Event	12	21	1	0
Overall Study Lost to Follow-up	62	69	4	3
Overall Study Protocol Violation	4	2	2	2
Overall Study Withdrawal by Subject	48	42	2	6

Baseline Characteristics

Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

Baseline characteristics by cohort

Measure	RotaTeq™ - Africa n=2733 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa n=2735 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia n=1018 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia n=1018 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Total n=7504 Participants Total of all reporting groups
Age, Customized <27 Days	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Age, Customized 27 to 41 Days	536 participants n=5 Participants	569 participants n=7 Participants	3 participants n=5 Participants	7 participants n=4 Participants	1115 participants n=21 Participants
Age, Customized 42 to 84 Days	2197 participants n=5 Participants	2165 participants n=7 Participants	1015 participants n=5 Participants	1011 participants n=4 Participants	6388 participants n=21 Participants
Sex: Female, Male Female	1359 Participants n=5 Participants	1370 Participants n=7 Participants	464 Participants n=5 Participants	492 Participants n=4 Participants	3685 Participants n=21 Participants
Sex: Female, Male Male	1374 Participants n=5 Participants	1365 Participants n=7 Participants	554 Participants n=5 Participants	526 Participants n=4 Participants	3819 Participants n=21 Participants
Race/Ethnicity, Customized Black	2733 participants n=5 Participants	2735 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	5468 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	1017 participants n=5 Participants	1016 participants n=4 Participants	2033 participants n=21 Participants
Race/Ethnicity, Customized Multi-Racial	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants

PRIMARY outcome

Timeframe: At least 14 days following the third vaccination

Population: Per Protocol Population

Outcome measures

Measure	RotaTeq™ - Africa n=2357 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa n=2348 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia n=991 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia n=978 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose Subjects with rotavirus gastroenteritis cases	79 Subjects	129 Subjects	38 Subjects	71 Subjects
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose Subjects without rotavirus gastroenteritis cases	2278 Subjects	2219 Subjects	953 Subjects	907 Subjects

SECONDARY outcome

Timeframe: 14 days following the 3rd vaccination

Population: Per Protocol Population \*N analyzed for Serotype P1A\[8\] is 188

Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

Outcome measures

Measure	RotaTeq™ - Africa n=189 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa n=169 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in anti-rotavirus IgA	148 Subjects	34 Subjects	—	—
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G1	35 Subjects	0 Subjects	—	—
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G2	17 Subjects	5 Subjects	—	—
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G3	12 Subjects	4 Subjects	—	—
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G4	50 Subjects	4 Subjects	—	—
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype P1A[8]	27 Subjects	8 Subjects	—	—

SECONDARY outcome

Timeframe: 14 days following the 3rd vaccination

Population: Per Protocol Population

Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

Outcome measures

Measure	RotaTeq™ - Africa n=131 Participants Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Africa n=132 Participants Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	RotaTeq™ - Asia Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.	Placebo - Asia Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in anti-rotavirus IgA	115 Subjects	24 Subjects	—	—
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G1	42 Subjects	3 Subjects	—	—
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G2	13 Subjects	1 Subjects	—	—
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G3	37 Subjects	4 Subjects	—	—
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype G4	24 Subjects	0 Subjects	—	—
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] ≥ 3 fold rise in antibody titer: Serotype P1A[8]	36 Subjects	7 Subjects	—	—

Adverse Events

RotaTeq™

Serious events: 144 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 156 serious events

Other events: 0 other events

Deaths: 0 deaths

RotaTeq™, Placebo, RotaTeq™

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Placebo, RotaTeq™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RotaTeq™ - Kenya Safety Cohort

Serious events: 0 serious events

Other events: 137 other events

Deaths: 0 deaths

Placebo - Kenya Safety Cohort

Serious events: 0 serious events

Other events: 147 other events

Deaths: 0 deaths

Serious adverse events

Measure	RotaTeq™ n=3744 participants at risk Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.	Placebo n=3745 participants at risk Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.	RotaTeq™, Placebo, RotaTeq™ n=3 participants at risk Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.	Placebo, Placebo, RotaTeq™ n=1 participants at risk Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.	RotaTeq™ - Kenya Safety Cohort n=149 participants at risk A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	Placebo - Kenya Safety Cohort n=152 participants at risk A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Blood and lymphatic system disorders Anemia	0.21% 8/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.13% 5/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Cardiac disorders Cardiac failure congestive	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Cardiac disorders Cardiopulmonary failure	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Diarrhea	0.11% 4/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.11% 4/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Inguinal hernia, obstructive	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Intussusception	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Vomiting	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Death	0.13% 5/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.19% 7/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Drowning	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Hypothermia	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Pyrexia	0.05% 2/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Sudden infant death syndrome	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.05% 2/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Hepatobiliary disorders Hepatic failure	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Abscess	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchiolitis	0.11% 4/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchitis	0.08% 3/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchopneumonia	0.16% 6/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.24% 9/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Cerebral malaria	0.05% 2/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Cytomegalovirus infection	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Dysentery	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Febrile infection	0.05% 2/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.11% 4/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Furuncle	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Gastroenteritis	1.2% 44/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 49/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations HIV infection	0.16% 6/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.19% 7/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Lobar pneumonia	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Malaria	0.91% 34/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.85% 32/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Meningitis	0.11% 4/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.16% 6/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Meningitis pneumococcal	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Omphalitis	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Oral candidiasis	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Oral infection	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Otitis media acute	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Pneumonia	1.2% 46/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.2% 44/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	33.3% 1/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Respiratory tract infection	0.19% 7/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.24% 9/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Rhinitis	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Salmonellosis	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.05% 2/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Sepsis	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.11% 4/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Tuberculosis	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Typhoid fever	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Upper respiratory tract infection	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.08% 3/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Urinary tract infection	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Chemical poisoning	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Drug toxicity	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Head injury	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Poisoning	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Snake bite	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Therapeutic agent toxicity	0.08% 3/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.08% 3/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Cachexia	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Dehydration	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.05% 2/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Feeding disorder of infancy or early childhood	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Malnutrition	0.13% 5/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.11% 4/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Metabolic disorder	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatoblastoma	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Nervous system disorders Convulsion	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Nervous system disorders Status epilepticus	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Renal and urinary disorders Nephrotic syndrome	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.08% 3/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.05% 2/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.03% 1/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3744 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.03% 1/3745 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/3 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/1 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Other adverse events

Measure	RotaTeq™ n=3744 participants at risk Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.	Placebo n=3745 participants at risk Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study. SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia). Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.	RotaTeq™, Placebo, RotaTeq™ n=3 participants at risk Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.	Placebo, Placebo, RotaTeq™ n=1 participants at risk Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned. Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.	RotaTeq™ - Kenya Safety Cohort n=149 participants at risk A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	Placebo - Kenya Safety Cohort n=152 participants at risk A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Blood and lymphatic system disorders Anaemia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.6% 4/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Congenital, familial and genetic disorders Phimosis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Ear and labyrinth disorders Otorrhoea	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Eye disorders Conjunctivitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	6.7% 10/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	8.6% 13/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Eye disorders Eye discharge	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Eye disorders Eye swelling	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Abdominal pain	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.7% 4/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Abdominal pain upper	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Constipation	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.4% 5/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Diarrhoea	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	47.7% 71/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	44.1% 67/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Diarrhoea haemorrhagic	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Dyspepsia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Enteritis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Faeces hard	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Glossodynia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Gastrointestinal disorders Vomiting	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	23.5% 35/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	20.4% 31/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Feeling hot	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Oedema peripheral	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
General disorders Pyrexia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	64.4% 96/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	64.5% 98/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Abscess	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Abscess of eyelid	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchiolitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.4% 5/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Bronchopneumonia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	6.7% 10/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	5.3% 8/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Cellulitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Dysentery	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Fungal infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Fungal skin infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Gastroenteritis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	26.2% 39/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	29.6% 45/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Impetigo	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Laryngitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Lower respiratory tract infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Malaria	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	15.4% 23/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	22.4% 34/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Nasopharyngitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Oral candidiasis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	10.1% 15/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	9.2% 14/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Oropharyngeal candidiasis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Otitis externa	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Otitis media	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Pharyngitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Pneumonia	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	10.7% 16/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	12.5% 19/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Respiratory tract infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.7% 4/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.6% 4/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Rhinitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	36.2% 54/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	40.8% 62/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Septic rash	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Sinusitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Tinea capitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.6% 4/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Tinea infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Tinea versicolour	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Tuberculosis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Umbilical sepsis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Upper respiratory tract infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.4% 5/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.9% 6/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Urinary tract infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Infections and infestations Viral infection	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Soft tissue injury	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Injury, poisoning and procedural complications Tongue injury	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Feeding disorder of infancy or early childhood	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Nervous system disorders Convulsion	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Nervous system disorders Crying	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Metabolism and nutrition disorders Fontanelle bulging	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Reproductive system and breast disorders Vaginal discharge	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Allergic cough	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Bronchospasm	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	4.7% 7/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.9% 6/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Cough	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	59.7% 89/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	59.2% 90/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Dyspnoea	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	14.8% 22/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	15.1% 23/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Hiccups	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Nasal congestion	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	20.1% 30/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	11.8% 18/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Dermatitis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Dermatitis allergic	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	3.4% 5/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	5.3% 8/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Dermatitis diaper	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	1.3% 2/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Heat rash	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	2.0% 3/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Hyperhidrosis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Pemphigus	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Pityriasis	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Pruritus generalized	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Rash	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	38.3% 57/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	36.8% 56/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Rash generalized	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.66% 1/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Skin and subcutaneous tissue disorders Urticaria	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	— 0/0 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.67% 1/149 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.	0.00% 0/152 • Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination. For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER