Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo (NCT NCT02598388)

Last Updated: 2025-02-04

Results Overview

A SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

578 participants

Primary outcome timeframe

Up to 1 year post dose 2 (up to Day 380)

Results posted on

2025-02-04

Participant Flow

Out of 578 randomized participants, 574 received at least one dose of study vaccine.

Participant milestones

Participant milestones
Measure	Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.
Overall Study STARTED	40	10	20	5	161	39	161	39	39	10	40	10
Overall Study COMPLETED	39	10	18	5	151	38	156	38	39	9	39	10
Overall Study NOT COMPLETED	1	0	2	0	10	1	5	1	0	1	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 2): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.
Overall Study Lost to Follow-up	1	1	5	1	2	1	0	1
Overall Study Withdrawal by Subject	0	0	2	0	2	0	1	0
Overall Study Other	0	1	3	0	1	0	0	0

Baseline Characteristics

Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=40 Participants Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (Healthy Participants) n=10 Participants Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=20 Participants Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (HIV-infected Participants) n=5 Participants HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) n=161 Participants Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) n=39 Participants Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) n=161 Participants HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) n=39 Participants HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=39 Participants Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (Healthy Participants) n=10 Participants Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=40 Participants HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (HIV-infected Participants) n=10 Participants HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Total n=574 Participants Total of all reporting groups
Age, Continuous	42 years STANDARD_DEVIATION 14.42 • n=5 Participants	47.3 years STANDARD_DEVIATION 11.84 • n=7 Participants	46.7 years STANDARD_DEVIATION 12.89 • n=5 Participants	46 years STANDARD_DEVIATION 8.63 • n=4 Participants	29.1 years STANDARD_DEVIATION 7.56 • n=21 Participants	28.4 years STANDARD_DEVIATION 7.37 • n=8 Participants	37.5 years STANDARD_DEVIATION 9.78 • n=8 Participants	38.9 years STANDARD_DEVIATION 8.74 • n=24 Participants	28 years STANDARD_DEVIATION 7.72 • n=42 Participants	26.9 years STANDARD_DEVIATION 12.56 • n=42 Participants	38.5 years STANDARD_DEVIATION 9.91 • n=42 Participants	41 years STANDARD_DEVIATION 9.78 • n=42 Participants	34.8 years STANDARD_DEVIATION 11.02 • n=36 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	69 Participants n=21 Participants	19 Participants n=8 Participants	95 Participants n=8 Participants	22 Participants n=24 Participants	20 Participants n=42 Participants	6 Participants n=42 Participants	26 Participants n=42 Participants	4 Participants n=42 Participants	289 Participants n=36 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	3 Participants n=7 Participants	18 Participants n=5 Participants	4 Participants n=4 Participants	92 Participants n=21 Participants	20 Participants n=8 Participants	66 Participants n=8 Participants	17 Participants n=24 Participants	19 Participants n=42 Participants	4 Participants n=42 Participants	14 Participants n=42 Participants	6 Participants n=42 Participants	285 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	20 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants	5 Participants n=4 Participants	154 Participants n=21 Participants	38 Participants n=8 Participants	158 Participants n=8 Participants	37 Participants n=24 Participants	38 Participants n=42 Participants	9 Participants n=42 Participants	40 Participants n=42 Participants	10 Participants n=42 Participants	554 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants	4 Participants n=4 Participants	160 Participants n=21 Participants	39 Participants n=8 Participants	159 Participants n=8 Participants	39 Participants n=24 Participants	39 Participants n=42 Participants	10 Participants n=42 Participants	40 Participants n=42 Participants	10 Participants n=42 Participants	538 Participants n=36 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	34 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Region of Enrollment KENYA	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	50 Participants n=21 Participants	9 Participants n=8 Participants	79 Participants n=8 Participants	21 Participants n=24 Participants	10 Participants n=42 Participants	6 Participants n=42 Participants	15 Participants n=42 Participants	7 Participants n=42 Participants	197 Participants n=36 Participants
Region of Enrollment MOZAMBIQUE	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	32 Participants n=21 Participants	7 Participants n=8 Participants	23 Participants n=8 Participants	5 Participants n=24 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	0 Participants n=42 Participants	83 Participants n=36 Participants
Region of Enrollment NIGERIA	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	17 Participants n=21 Participants	3 Participants n=8 Participants	11 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	38 Participants n=36 Participants
Region of Enrollment TANZANIA, UNITED REPUBLIC OF	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	31 Participants n=21 Participants	9 Participants n=8 Participants	14 Participants n=8 Participants	4 Participants n=24 Participants	11 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	75 Participants n=36 Participants
Region of Enrollment UGANDA	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	31 Participants n=21 Participants	11 Participants n=8 Participants	34 Participants n=8 Participants	8 Participants n=24 Participants	8 Participants n=42 Participants	0 Participants n=42 Participants	13 Participants n=42 Participants	1 Participants n=42 Participants	106 Participants n=36 Participants
Region of Enrollment UNITED STATES	40 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	75 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 28 days post each dose (up to Day 43)

Population: Safety set was based on full analysis set (FAS) which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=60 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=15 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Number of Participants With Unsolicited Adverse Events	33 Participants	10 Participants	32 Participants	3 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 days post dose 2 visit (up to Day 57)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited adverse events were events which were reported by the participant voluntarily or obtained by means of interviewing the participant in a nondirected manner at study visits.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=39 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=39 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): Number of Participants With Unsolicited Adverse Events	83 Participants	21 Participants	78 Participants	15 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year post dose 2 (up to Day 380)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=60 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=15 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Number of Participants With Serious Adverse Events (SAEs)	1 Participants	1 Participants	3 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year post dose 2 (up to Day 394)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=39 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=39 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): Number of Participants With SAEs	1 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year post dose 2 (up to Day 380)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

The following neuroinflammatory disorders were considered immediate reportable events and which had to be reported to the sponsor within 24 hours of becoming aware of the event: cranial nerve disorders including paralyses/paresis (example: bell's palsy), optic neuritis, multiple sclerosis, transverse myelitis, guillain-barre syndrome including miller fisher syndrome, bickerstaff's encephalitis and other variants, acute disseminated encephalomyelitis, including site-specific variants (example: non-infectious encephalitis, encephalomyelitis, myelitis, myeloradiculomyelitis), myasthenia gravis and lambert-eaton myasthenic syndrome, immune-mediated peripheral neuropathies and plexopathies, including chronic inflammatory, demyelinating polyneuropathy, multifocal motor neuropathy, and polyneuropathies associated with monoclonal gammopathy, narcolepsy, isolated paresthesia of more than 7 days duration.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=60 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=15 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Number of Participants With Immediate Reportable Events (IREs)	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to 1 year post dose 2 (up to Day 394)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=39 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=39 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): Number of Participants With IREs	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post dose 1 (up to Day 8)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post first vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=60 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=15 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) n=161 Participants Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) n=39 Participants Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) n=161 Participants HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) n=39 Participants HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Parts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) 7 Days Post First Vaccination	46 Participants	5 Participants	34 Participants	3 Participants	71 Participants	10 Participants	75 Participants	7 Participants

PRIMARY outcome

Timeframe: 7 days post dose 2 (up to Day 22)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for 7 days post second vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=78 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=58 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=14 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination	44 Participants	4 Participants	33 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post dose 2 (up to Day 36)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=159 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=37 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=160 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=38 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): Number of Participants With Solicited Local AEs 7 Days Post Second Vaccination	82 Participants	7 Participants	64 Participants	7 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post dose 1 (up to Day 8)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events included fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=60 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=15 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) n=161 Participants Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) n=39 Participants Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) n=161 Participants HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) n=39 Participants HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Parts 1 and 2: Number of Participants With Solicited Systemic Adverse Events 7 Days Post First Vaccination	39 Participants	10 Participants	37 Participants	7 Participants	109 Participants	24 Participants	97 Participants	18 Participants

PRIMARY outcome

Timeframe: 7 days post dose 2 (up to Day 22)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=78 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=20 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=58 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=14 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination	45 Participants	8 Participants	35 Participants	4 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post dose 2 (up to Day 36)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=159 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=37 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=160 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=38 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): Number of Participants With Solicited Systemic AEs 7 Days Post Second Vaccination	83 Participants	20 Participants	80 Participants	10 Participants	—	—	—	—

PRIMARY outcome

Timeframe: 21-days post dose 2 (up to Day 36)

Population: The per protocol analysis set included all randomized and vaccinated participants, who received both the dose 1 and dose 2 vaccinations (administered within the protocol-defined visit window), had at least 1 post-vaccination (that is, after the date of vaccination) evaluable immunogenicity sample, and had no major protocol violations influencing the immune responses. Here, N (number of participants analyzed) signifies number of participants that were evaluable for this outcome measure.

GMCs of antibodies binding to EBOV GP using FANG ELISA were reported and were measured in ELISA unit per milliliter (EU/mL). Serum samples were collected for analysis of binding antibodies against EBOV GP using FANG ELISA to determine humoral responses following vaccination. A sample was considered positive, if the value was above the lower limit of quantification (LLOQ), that is, 36.11 ELISA units/mL. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=68 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=18 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=56 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=13 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 1, Part 2 (Group 2): Geometric Mean Concentrations (GMCs) of Binding Antibody Levels Against Ebola Virus Glycoprotein (EBOV GP) Measured Using Filovirus Animal Non-Clinical Group (FANG) Enzyme-linked Immunosorbent Assay (ELISA)	5733 EU/mL Interval 4245.0 to 7742.0	40 EU/mL Interval to 112.0 Here, 'NA' signifies that lower limit of calculated 95% CI was less than LLOQ.	2325 EU/mL Interval 1632.0 to 3313.0	NA EU/mL Interval to 38.0 Here, 'NA' signifies that geometric mean and lower limit of calculated 95% CI was less than LLOQ.	—	—	—	—

PRIMARY outcome

Timeframe: 21-days post dose 2 (Day 50)

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=151 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=34 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=155 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=36 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Part 2 (Group 1): GMCs of Binding Antibody Levels Against EBOV GP Measured Using FANG ELISA	6037 EU/mL Interval 4996.0 to 7297.0	NA EU/mL Here, "NA" signifies that calculated Geometric mean and the limits of the 95% CI were less than LLOQ	2939 EU/mL Interval 2316.0 to 3729.0	NA EU/mL Here, "NA" signifies that calculated Geometric mean and the limits of the 95% CI were less than LLOQ	—	—	—	—

SECONDARY outcome

Timeframe: Solicited AEs: Up to 7 days post each vaccination (Up to Day 36); Unsolicited AEs: Up to 28 days post each vaccination (Up to Day 57)

Population: Safety set was based on FAS which included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. As per planned analysis, the data from Parts 1 and 2 (Group 2) of the study was pooled (that is, 14-day interval regimen) and presented separately for the healthy and HIV-infected cohorts. This outcome measure was planned to compare the safety (unsolicited AEs, solicited local and solicited systemic AEs) of Ad26.ZEBOV/MVA-BN-Filo and MVA-BN-Filo/Ad26.ZEBOV regimens in healthy and HIV-infected participants. Therefore, placebo arm is not reported.

Outcome measures

Outcome measures
Measure	Healthy (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=79 Participants Healthy participants in Part 1 and Part 2 (Group 2) received intramuscular (IM) injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	Healthy (Part 1, Part 2; Group 2): Placebo n=60 Participants Healthy participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): MVA-BN-Filo and Ad26.ZEBOV n=161 Participants Human immunodeficiency virus (HIV)- infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose MVA-BN-Filo (Dose 1) on Day 1 followed by IM injection of single dose Ad26.ZEBOV (Dose 2) at Day 15.	HIV-infected (Part 1, Part 2; Group 2): Placebo n=161 Participants HIV-infected participants in Part 1 and Part 2 (Group 2) received IM injection of single dose placebo (Dose 1) on Day 1 followed by IM injection of single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Number of Participants With Adverse Events Unsolicited AEs	33 Participants	32 Participants	83 Participants	78 Participants	—	—	—	—
Number of Participants With Adverse Events Solicited Local AEs	56 Participants	47 Participants	103 Participants	93 Participants	—	—	—	—
Number of Participants With Adverse Events Solicited Systemic AEs	56 Participants	46 Participants	116 Participants	117 Participants	—	—	—	—

Adverse Events

Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1: Placebo (Healthy Participants)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 1: Placebo (HIV-infected Participants)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 2 (Group 2): Placebo (Healthy Participants)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Part 2 (Group 2): Placebo (HIV-infected Participants)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants)

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Part 2 (Group 1): Placebo (Healthy Participants)

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants)

Serious events: 2 serious events

Other events: 51 other events

Deaths: 0 deaths

Part 2 (Group 1): Placebo (HIV-infected Participants)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=40 participants at risk Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (Healthy Participants) n=10 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=20 participants at risk Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (HIV-infected Participants) n=5 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=39 participants at risk Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (Healthy Participants) n=10 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=40 participants at risk HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (HIV-infected Participants) n=10 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) n=161 participants at risk Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) n=39 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) n=161 participants at risk HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) n=39 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Peptic Ulcer	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Immune system disorders Anaphylactic Reaction	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Appendicitis Perforated	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Malaria	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Postoperative Wound Infection	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Staphylococcal Osteomyelitis	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	20.0% 1/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Typhoid Fever	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Soft Tissue Injury	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Wound	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Cervical Cord Compression	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	20.0% 1/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Psychiatric disorders Panic Attack	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Vascular disorders Deep Vein Thrombosis	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Other adverse events

Other adverse events
Measure	Part 1: MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=40 participants at risk Healthy participants received an intramuscular (IM) injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (Healthy Participants) n=10 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 1: MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=20 participants at risk Human immunodeficiency virus (HIV) infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 1: Placebo (HIV-infected Participants) n=5 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (Healthy Participants) n=39 participants at risk Healthy participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (Healthy Participants) n=10 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 2): MVA-BN-Filo and Ad26.ZEBOV (HIV-infected Participants) n=40 participants at risk HIV-infected participants received an IM injection of a single dose MVA-BN-Filo (Dose 1) at Day 1 followed by an IM injection of a single dose Ad26.ZEBOV (Dose 2) at Day 15.	Part 2 (Group 2): Placebo (HIV-infected Participants) n=10 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 15.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (Healthy Participants) n=161 participants at risk Healthy participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (Healthy Participants) n=39 participants at risk Healthy participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.	Part 2 (Group 1): Ad26.ZEBOV and MVA-BN-Filo (HIV-infected Participants) n=161 participants at risk HIV-infected participants received an IM injection of a single dose Ad26.ZEBOV (Dose 1) at Day 1 followed by an IM injection of a single dose MVA-BN-Filo (Dose 2) at Day 29.	Part 2 (Group 1): Placebo (HIV-infected Participants) n=39 participants at risk HIV-infected participants received an IM injection of a single dose placebo (Dose 1) at Day 1 followed by an IM injection of a single dose placebo (Dose 2) at Day 29.
Gastrointestinal disorders Gastritis	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.3% 4/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Nausea	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Toothache	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
General disorders Injection Site Erosion	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Body Tinea	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
General disorders Fatigue	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Blood and lymphatic system disorders Anaemia	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	15.0% 3/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.1% 2/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Abdominal Pain	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Dental Caries	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Gastroenteritis	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Influenza	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 3/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Malaria	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.3% 4/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	20.0% 2/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	3.1% 5/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	3.1% 5/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Otitis Media	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Pharyngitis	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 2/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 4/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Rash Pustular	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Rhinitis	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.1% 2/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Infections and infestations Upper Respiratory Tract Infection	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	12.8% 5/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	30.0% 3/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	7.5% 3/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	30.0% 3/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	14.3% 23/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.3% 4/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	15.5% 25/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	12.8% 5/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Apheresis Related Complication	7.5% 3/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Injury, poisoning and procedural complications Soft Tissue Injury	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Investigations Alanine Aminotransferase Increased	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.9% 3/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 3/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 4/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	5.0% 2/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Dizziness	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Headache	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 4/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.6% 9/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	7.7% 3/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.6% 9/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.6% 1/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Paraesthesia	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.1% 2/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Nervous system disorders Presyncope	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.0% 1/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	5.1% 2/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	1.2% 2/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	10.0% 1/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.
Vascular disorders Hypertension	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	20.0% 2/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/20 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/5 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	2.5% 1/40 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/10 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.62% 1/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/161 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.	0.00% 0/39 • Up to Day 380 (Part 1, Part 2; Group 2) and Up to Day 394 (Part 2; Group 1) Safety set included all participants who were randomized and received at least 1 dose of study vaccine, regardless of the occurrence of protocol deviations.

Additional Information

MEDICAL LEADER

Janssen Vaccines & Prevention B.V.

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER