Trial Outcomes & Findings for A Study of Ad26.COV2.S in Adults (COVID-19) (NCT NCT04436276)

Results Overview

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

1085 participants

Primary outcome timeframe

7 days post-vaccination 1 on Day 1 (Day 8)

Results posted on

2025-02-04

Participant Flow

A total of 1085 participants were enrolled in the study, out of which 1076 participants received treatment. Remaining 9 participants did not receive any treatment and are excluded from the analyses.

Participant milestones

Participant milestones
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo (PL) on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.	COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\10\^10 vp after 12 months as Booster 2.	COHORT 2A: Placebo, B: PL Group 5 healthy adult participants received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2).	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.	COHORT 2B: Placebo, B: PL Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Overall Study STARTED	77	75	75	73	77	5	5	5	5	5	58	29	32	17	62	30	28	15	81	80	82	79	81
Overall Study Dose 1	77	75	75	73	77	5	5	5	5	5	58	29	32	17	62	30	28	15	81	80	82	79	81
Overall Study Dose 2	74	74	74	67	74	4	5	5	5	5	0	0	0	0	56	29	27	14	77	80	80	78	79
Overall Study Ad Hoc Booster Dose	6	8	7	7	0	1	2	2	0	0	4	0	0	0	7	0	0	0	11	15	14	9	0
Overall Study Post Booster 1 Dose	0	0	0	0	0	0	0	0	0	0	42	19	20	1	45	21	20	0	0	0	0	0	0
Overall Study Post Booster 2 Dose	0	0	0	0	0	0	0	0	0	0	19	13	10	0	8	3	5	0	0	0	0	0	0
Overall Study COMPLETED	48	49	42	39	36	3	5	4	4	4	33	15	14	7	31	16	15	5	65	53	53	57	6
Overall Study NOT COMPLETED	29	26	33	34	41	2	0	1	1	1	25	14	18	10	31	14	13	10	16	27	29	22	75

Reasons for withdrawal

Reasons for withdrawal
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo (PL) on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.	COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\10\^10 vp after 12 months as Booster 2.	COHORT 2A: Placebo, B: PL Group 5 healthy adult participants received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2).	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.	COHORT 2B: Placebo, B: PL Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Overall Study Adverse Event	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Overall Study Death	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	2	0	1	0
Overall Study Lost to Follow-up	0	2	2	1	4	1	0	1	0	5	5	4	1	7	7	1	0	1	1	2	1	1
Overall Study Physician Decision	1	0	2	1	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	1	2	0
Overall Study Protocol Violation	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	25	22	24	23	14	0	1	0	1	17	7	10	6	20	6	11	4	14	24	24	16	14
Overall Study Other	3	2	5	9	23	1	0	0	0	3	1	1	2	3	0	0	6	1	0	2	2	60

Baseline Characteristics

A Study of Ad26.COV2.S in Adults (COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=58 Participants Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL n=29 Participants Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.	COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 n=32 Participants Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\10\^10 vp after 12 months as Booster 2.	COHORT 2A: Placebo, B: PL n=17 Participants Group 5 healthy adult participants received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=62 Participants Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL n=30 Participants Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2).	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 n=28 Participants Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.	COHORT 2B: Placebo, B: PL n=15 Participants Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	Total n=1076 Participants Total of all reporting groups
Age, Customized Adults (18-64 years)	77 Participants n=5 Participants	75 Participants n=7 Participants	75 Participants n=5 Participants	73 Participants n=4 Participants	77 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	5 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	58 Participants n=42 Participants	29 Participants n=42 Participants	32 Participants n=36 Participants	17 Participants n=36 Participants	62 Participants n=24 Participants	30 Participants n=135 Participants	28 Participants n=136 Participants	15 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	673 Participants n=11 Participants
Age, Customized From 65 to 84 years	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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	81 Participants n=667 Participants	80 Participants n=12 Participants	81 Participants n=12 Participants	78 Participants n=12 Participants	81 Participants n=12 Participants	401 Participants n=11 Participants
Age, Continuous	35.4 years STANDARD_DEVIATION 10.11 • n=5 Participants	35.7 years STANDARD_DEVIATION 9.99 • n=7 Participants	34.5 years STANDARD_DEVIATION 10.59 • n=5 Participants	35.1 years STANDARD_DEVIATION 10.48 • n=4 Participants	35 years STANDARD_DEVIATION 9.88 • n=21 Participants	43 years STANDARD_DEVIATION 11.45 • n=8 Participants	44.4 years STANDARD_DEVIATION 4.39 • n=8 Participants	29.6 years STANDARD_DEVIATION 4.34 • n=24 Participants	41.2 years STANDARD_DEVIATION 5.54 • n=42 Participants	40.8 years STANDARD_DEVIATION 11.97 • n=42 Participants	36.8 years STANDARD_DEVIATION 9.27 • n=42 Participants	38.1 years STANDARD_DEVIATION 9.98 • n=42 Participants	39.2 years STANDARD_DEVIATION 10.53 • n=36 Participants	37.5 years STANDARD_DEVIATION 10.41 • n=36 Participants	37.6 years STANDARD_DEVIATION 9.93 • n=24 Participants	38.3 years STANDARD_DEVIATION 9.81 • n=135 Participants	36.1 years STANDARD_DEVIATION 11.48 • n=136 Participants	37 years STANDARD_DEVIATION 9.99 • n=44 Participants	69.5 years STANDARD_DEVIATION 4.24 • n=667 Participants	69.8 years STANDARD_DEVIATION 3.74 • n=12 Participants	69.7 years STANDARD_DEVIATION 4.33 • n=12 Participants	70.3 years STANDARD_DEVIATION 4.18 • n=12 Participants	69.9 years STANDARD_DEVIATION 3.73 • n=12 Participants	48.9 years STANDARD_DEVIATION 18.27 • n=11 Participants
Age, Customized Children (2-11 years)	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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants
Age, Customized Adolescents (12-17 years)	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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants
Age, Customized 85 years and over	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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	2 Participants n=11 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	42 Participants n=4 Participants	39 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	33 Participants n=42 Participants	15 Participants n=42 Participants	12 Participants n=36 Participants	10 Participants n=36 Participants	23 Participants n=24 Participants	10 Participants n=135 Participants	15 Participants n=136 Participants	10 Participants n=44 Participants	40 Participants n=667 Participants	36 Participants n=12 Participants	42 Participants n=12 Participants	40 Participants n=12 Participants	43 Participants n=12 Participants	541 Participants n=11 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	31 Participants n=4 Participants	38 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	25 Participants n=42 Participants	14 Participants n=42 Participants	20 Participants n=36 Participants	7 Participants n=36 Participants	39 Participants n=24 Participants	20 Participants n=135 Participants	13 Participants n=136 Participants	5 Participants n=44 Participants	41 Participants n=667 Participants	44 Participants n=12 Participants	40 Participants n=12 Participants	39 Participants n=12 Participants	38 Participants n=12 Participants	535 Participants n=11 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=36 Participants	2 Participants n=36 Participants	5 Participants n=24 Participants	2 Participants n=135 Participants	2 Participants n=136 Participants	3 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=12 Participants	2 Participants n=12 Participants	0 Participants n=12 Participants	3 Participants n=12 Participants	46 Participants n=11 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	69 Participants n=7 Participants	73 Participants n=5 Participants	71 Participants n=4 Participants	72 Participants n=21 Participants	5 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	55 Participants n=42 Participants	26 Participants n=42 Participants	28 Participants n=36 Participants	14 Participants n=36 Participants	56 Participants n=24 Participants	28 Participants n=135 Participants	25 Participants n=136 Participants	12 Participants n=44 Participants	81 Participants n=667 Participants	78 Participants n=12 Participants	80 Participants n=12 Participants	79 Participants n=12 Participants	78 Participants n=12 Participants	1021 Participants n=11 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 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	1 Participants n=42 Participants	0 Participants n=36 Participants	1 Participants n=36 Participants	1 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	9 Participants n=11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	3 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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	4 Participants n=11 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants	4 Participants n=24 Participants	5 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	28 Participants n=11 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	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=11 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	9 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	4 Participants n=42 Participants	4 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	2 Participants n=24 Participants	2 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	1 Participants n=667 Participants	0 Participants n=12 Participants	1 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	38 Participants n=11 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants	71 Participants n=7 Participants	70 Participants n=5 Participants	66 Participants n=4 Participants	65 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	5 Participants n=42 Participants	49 Participants n=42 Participants	22 Participants n=42 Participants	28 Participants n=36 Participants	15 Participants n=36 Participants	55 Participants n=24 Participants	22 Participants n=135 Participants	26 Participants n=136 Participants	14 Participants n=44 Participants	80 Participants n=667 Participants	77 Participants n=12 Participants	80 Participants n=12 Participants	78 Participants n=12 Participants	81 Participants n=12 Participants	992 Participants n=11 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	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	3 Participants n=11 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	3 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	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	1 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	1 Participants n=44 Participants	0 Participants n=667 Participants	2 Participants n=12 Participants	1 Participants n=12 Participants	0 Participants n=12 Participants	0 Participants n=12 Participants	11 Participants n=11 Participants

PRIMARY outcome

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Population: Full analysis set (FAS) included all participants with at least one vaccine administration documented.

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	50 Participants	50 Participants	57 Participants	59 Participants	8 Participants	4 Participants	3 Participants	5 Participants	4 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=67 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	49 Participants	5 Participants	55 Participants	7 Participants	2 Participants	4 Participants	0 Participants	5 Participants	1 Participants	0 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	5 Participants	5 Participants	6 Participants	5 Participants	—	0 Participants	1 Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1 on Day 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=58 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=32 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=17 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=62 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a and 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	48 Participants	24 Participants	19 Participants	4 Participants	52 Participants	23 Participants	18 Participants	0 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 1 on Day 183 (Day 190)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2a were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=42 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1	6 Participants	15 Participants	3 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 2 on Day 366 (Day 373)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.

Number of participants with solicited local AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=13 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=10 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2	3 Participants	3 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited local AEs for 7 days after Vaccination 2 in Cohort 2b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=56 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=27 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	42 Participants	21 Participants	18 Participants	3 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 1 on Day 239 (Day 246)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 1 in the respective arm.

Number of participants with solicited local AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=45 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=21 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 1	4 Participants	15 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 2 on Day 422 (Day 429)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arms.

Number of participants with solicited local AEs for 7 days after booster Vaccination 2 in Cohort 2b were reported. 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Booster Vaccination 2	0 Participants	1 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after vaccination 1 on Day 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 1a and 1b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	48 Participants	52 Participants	63 Participants	62 Participants	17 Participants	4 Participants	3 Participants	5 Participants	5 Participants	4 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohorts 1a and 1b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=67 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	43 Participants	23 Participants	51 Participants	19 Participants	15 Participants	3 Participants	2 Participants	4 Participants	1 Participants	3 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 488 up to Day 604)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post Ad Hoc Booster Vaccination (day of Ad hoc booster vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	5 Participants	6 Participants	3 Participants	4 Participants	—	0 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1 on Day 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohorts 2a and 2b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=58 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=32 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=17 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=62 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a and 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	47 Participants	23 Participants	21 Participants	8 Participants	50 Participants	23 Participants	21 Participants	5 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 1 on Day 183 (Day 190)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited systemic AEs for 7 days post booster vaccination 1 in Cohort 2a were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=42 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1	14 Participants	11 Participants	5 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 2 on Day 366 (Day 373)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 2 in the respective arm.

Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2a were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=13 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=10 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2	6 Participants	2 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 384 up to Day 451)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2a were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post adhoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 2b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=56 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=27 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	40 Participants	17 Participants	15 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 1 on Day 239 (Day 246)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 1 in the respective arm.

Number of participants with solicited systemic AEs for 7 days after booster vaccination 1 in Cohort 2b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=45 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=21 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 1	14 Participants	13 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination 2 on Day 422 (Day 429)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.

Number of participants with solicited systemic AEs for 7 days after booster vaccination 2 in Cohort 2b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Booster Vaccination 2	2 Participants	2 Participants	4 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 369 up to Day 412)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after vaccination 1 on Day 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with solicited local AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=81 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	38 Participants	30 Participants	33 Participants	34 Participants	7 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 1 on Day 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with solicited systemic AEs for 7 days after vaccination 1 in Cohort 3 were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=81 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1 in the Primary Regimen	39 Participants	35 Participants	47 Participants	42 Participants	20 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days post-vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited local AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=78 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	41 Participants	5 Participants	51 Participants	13 Participants	11 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 after post-vaccination 2 on Day 57 (Day 64)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with solicited systemic AEs for 7 days after vaccination 2 in Cohort 3 were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=78 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 2 in the Primary Regimen	33 Participants	24 Participants	40 Participants	24 Participants	24 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arm.

Number of participants with solicited local AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was 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. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=9 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	5 Participants	6 Participants	4 Participants	5 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after ad hoc booster vaccination (Day 456 up to Day 711)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with solicited systemic AEs for 7 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was 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. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post ad hoc booster vaccination (day of ad hoc booster vaccination and the subsequent 7 days).

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=9 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Ad Hoc Booster Vaccination	3 Participants	7 Participants	4 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after vaccination 1 on Day 1 (Day 29)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with unsolicited AEs after vaccination 1 in Cohorts 1a and 1b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen	11 Participants	20 Participants	26 Participants	24 Participants	14 Participants	2 Participants	3 Participants	4 Participants	4 Participants	2 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after vaccination 2 on Day 57 (Day 85)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with unsolicited AEs after vaccination 2 in Cohorts 1a and 1b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=67 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen	10 Participants	4 Participants	7 Participants	12 Participants	6 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after ad hoc booster vaccination (Day 488 up to Day 625)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohorts 1a and 1b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination	0 Participants	1 Participants	1 Participants	0 Participants	—	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 on Day 1 (Day 29)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with unsolicited AEs after vaccination 1 in Cohorts 2a and 2b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=58 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=32 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=17 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=62 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a and 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen	15 Participants	5 Participants	7 Participants	5 Participants	11 Participants	6 Participants	5 Participants	2 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after booster vaccination 1 on Day 183 (Day 211)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with unsolicited AEs after booster 1 vaccination in Cohort 2a were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=42 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=1 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1	2 Participants	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after booster vaccination 2 on Day 366 (Day 394)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 2 in the respective arm.

Number of participants with unsolicited AEs after booster vaccination 2 in Cohort 2a were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=19 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=13 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=10 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2	2 Participants	1 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after ad hoc booster vaccination (Day 384 up to Day 472)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with unsolicited AEs after ad hoc booster vaccination in Cohort 2a were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=4 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 on Day 57 (Day 85)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with unsolicited AEs after vaccination 1 in Cohort 2b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=56 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=27 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen	7 Participants	4 Participants	3 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after booster vaccination 1 on Day 239 (Day 267)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster Vaccination 1 in the respective arm.

Number of participants with unsolicited AEs 28 days after booster vaccination 1 in Cohort 2b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=45 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=21 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=20 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 1	1 Participants	4 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after booster vaccination 2 on Day 422 (Day 450)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received booster vaccination 2 in the respective arm.

Number of participants with unsolicited AEs 28 days after booster vaccination 2 in Cohort 2b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=8 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Booster Vaccination 2	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after ad hoc booster vaccination (Day 369 up to Day 433)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arms.

Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 2b were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=7 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination	0 Participants	—	—	—	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after vaccination 1 on Day 1 (Day 29)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with unsolicited AEs 28 days after vaccination 1 in Cohort 3 were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=81 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 1 in the Primary Regimen	16 Participants	13 Participants	19 Participants	26 Participants	16 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after vaccination 2 on Day 57 (Day 85)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with unsolicited AEs 28 days after vaccination 2 in Cohort 3 were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=80 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=78 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=79 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Vaccination 2 in the Primary Regimen	11 Participants	9 Participants	12 Participants	12 Participants	9 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after ad hoc booster vaccination (Day 456 up to Day 732)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who received Ad Hoc booster vaccination and were evaluable for this outcome measure. Here, 0 in the "Overall Number of Participants Analyzed" field signifies that no participants were available for the analysis because none of the participants received ad hoc booster vaccination in the respective arm.

Number of participants with unsolicited AEs 28 days after ad hoc booster vaccination in Cohort 3 were reported. An AE was 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 AEs were all AEs for which the participant is not specifically questioned in the participant diary.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=14 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=9 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days After Ad Hoc Booster Vaccination	1 Participants	0 Participants	3 Participants	1 Participants	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

Population: FAS included all participants with at least one vaccine administration documented.

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. An SAE is an AE 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a and 1b and Cohort 3: Number of Participants With Serious Adverse Events (SAEs)	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

Population: FAS included all participants with at least one vaccine administration documented.

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. An SAE is an AE 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/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=58 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=32 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=17 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=62 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a and 2b: Number of Participants With Serious Adverse Events (SAEs)	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 up to 2 years after Vaccination 2 on Day 57 (Day 787)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo n=81 Participants Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 1a, 1b and 3: Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 up to 6 months post primary regimen (up to Day 183 for Cohort 2a; up to Day 239 for Cohort 2b)

Population: FAS included all participants with at least one vaccine administration documented.

Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=58 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=32 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=17 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=62 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a and 2b: Number of Participants With Adverse Events of Special Interest (AESIs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29, 57, 71, 85, 239, and 422

Population: Per protocol immunogenicity (PPI) population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=65 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=64 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=67 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=64 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=70 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 422	100.0 Percentage of participants Interval 91.8 to 100.0	92.0 Percentage of participants Interval 80.8 to 97.8	100.0 Percentage of participants Interval 92.3 to 100.0	100.0 Percentage of participants Interval 91.6 to 100.0	66.7 Percentage of participants Interval 22.3 to 95.7	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 29	98.4 Percentage of participants Interval 91.5 to 100.0	98.4 Percentage of participants Interval 91.5 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	98.4 Percentage of participants Interval 91.6 to 100.0	1.4 Percentage of participants Interval 0.0 to 7.7	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 57	100.0 Percentage of participants Interval 94.4 to 100.0	98.4 Percentage of participants Interval 91.6 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	96.7 Percentage of participants Interval 88.7 to 99.6	1.5 Percentage of participants Interval 0.0 to 8.2	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 71	100.0 Percentage of participants Interval 94.1 to 100.0	100.0 Percentage of participants Interval 93.9 to 100.0	100.0 Percentage of participants Interval 94.4 to 100.0	96.4 Percentage of participants Interval 87.7 to 99.6	1.6 Percentage of participants Interval 0.0 to 8.8	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 85	100.0 Percentage of participants Interval 94.3 to 100.0	98.4 Percentage of participants Interval 91.2 to 100.0	100.0 Percentage of participants Interval 94.3 to 100.0	96.6 Percentage of participants Interval 88.1 to 99.6	4.7 Percentage of participants Interval 1.0 to 13.1	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 239	100.0 Percentage of participants Interval 94.0 to 100.0	98.3 Percentage of participants Interval 90.9 to 100.0	100.0 Percentage of participants Interval 93.6 to 100.0	94.2 Percentage of participants Interval 84.1 to 98.8	2.0 Percentage of participants Interval 0.1 to 10.9	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29 and 71

Population: PPI population included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=4 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 29	80.0 Percentage of participants Interval 28.4 to 99.5	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 47.8 to 100.0	0.0 Percentage of participants Interval 0.0 to 60.2	—	—	—	—	—	—	—	—	—	—
Cohort 1b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 71	100.0 Percentage of participants Interval 39.8 to 100.0	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 47.8 to 100.0	0.0 Percentage of participants Interval 0.0 to 60.2	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 29, 183, 190, 211, 366, 373, and 394,

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=51 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=26 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 8	6.0 Percentage of participants Interval 1.3 to 16.5	0.0 Percentage of participants Interval 0.0 to 14.8	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 21.8	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 29	98.0 Percentage of participants Interval 89.4 to 99.9	100.0 Percentage of participants Interval 85.2 to 100.0	100.0 Percentage of participants Interval 86.8 to 100.0	6.7 Percentage of participants Interval 0.2 to 31.9	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 183	97.0 Percentage of participants Interval 84.2 to 99.9	100.0 Percentage of participants Interval 81.5 to 100.0	86.7 Percentage of participants Interval 59.5 to 98.3	100.0 Percentage of participants Interval 2.5 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 190	96.8 Percentage of participants Interval 83.3 to 99.9	100.0 Percentage of participants Interval 79.4 to 100.0	92.3 Percentage of participants Interval 64.0 to 99.8	100.0 Percentage of participants Interval 2.5 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 211	100.0 Percentage of participants Interval 87.2 to 100.0	100.0 Percentage of participants Interval 76.8 to 100.0	85.7 Percentage of participants Interval 57.2 to 98.2	100.0 Percentage of participants Interval 2.5 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 366	95.2 Percentage of participants Interval 76.2 to 99.9	100.0 Percentage of participants Interval 75.3 to 100.0	83.3 Percentage of participants Interval 35.9 to 99.6	—	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 373	94.1 Percentage of participants Interval 71.3 to 99.9	100.0 Percentage of participants Interval 71.5 to 100.0	100.0 Percentage of participants Interval 39.8 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 394	92.3 Percentage of participants Interval 64.0 to 99.8	100.0 Percentage of participants Interval 71.5 to 100.0	100.0 Percentage of participants Interval 29.2 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 8, 29, 57, 64, 85, 239, 246, 267 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=51 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=24 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=12 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 8	0.0 Percentage of participants Interval 0.0 to 7.0	3.8 Percentage of participants Interval 0.1 to 19.6	4.5 Percentage of participants Interval 0.1 to 22.8	0.0 Percentage of participants Interval 0.0 to 26.5	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 29	95.9 Percentage of participants Interval 86.0 to 99.5	96.4 Percentage of participants Interval 81.7 to 99.9	100.0 Percentage of participants Interval 84.6 to 100.0	0.0 Percentage of participants Interval 0.0 to 26.5	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 57	95.8 Percentage of participants Interval 85.7 to 99.5	100.0 Percentage of participants Interval 86.8 to 100.0	100.0 Percentage of participants Interval 84.6 to 100.0	0.0 Percentage of participants Interval 0.0 to 26.5	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 64	100.0 Percentage of participants Interval 92.1 to 100.0	100.0 Percentage of participants Interval 85.8 to 100.0	100.0 Percentage of participants Interval 83.9 to 100.0	0.0 Percentage of participants Interval 0.0 to 28.5	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 267	97.2 Percentage of participants Interval 85.5 to 99.9	100.0 Percentage of participants Interval 81.5 to 100.0	93.8 Percentage of participants Interval 69.8 to 99.8	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 422	100.0 Percentage of participants Interval 47.8 to 100.0	100.0 Percentage of participants Interval 29.2 to 100.0	100.0 Percentage of participants Interval 29.2 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 85	97.8 Percentage of participants Interval 88.2 to 99.9	100.0 Percentage of participants Interval 86.8 to 100.0	100.0 Percentage of participants Interval 82.4 to 100.0	0.0 Percentage of participants Interval 0.0 to 28.5	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 239	97.4 Percentage of participants Interval 86.5 to 99.9	95.5 Percentage of participants Interval 77.2 to 99.9	94.4 Percentage of participants Interval 72.7 to 99.9	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 246	97.4 Percentage of participants Interval 86.2 to 99.9	100.0 Percentage of participants Interval 78.2 to 100.0	93.8 Percentage of participants Interval 69.8 to 99.8	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points.

Percentage of participants with antibodies binding to SARS-CoV-2 S protein as measured by ELISA was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=72 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=73 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=74 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=75 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 100	98.4 Percentage of participants Interval 91.6 to 100.0	97.1 Percentage of participants Interval 89.8 to 99.6	98.4 Percentage of participants Interval 91.6 to 100.0	98.6 Percentage of participants Interval 92.3 to 100.0	0.0 Percentage of participants Interval 0.0 to 5.4	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 15	78.0 Percentage of participants Interval 65.3 to 87.7	72.4 Percentage of participants Interval 59.1 to 83.3	79.6 Percentage of participants Interval 66.5 to 89.4	77.4 Percentage of participants Interval 65.0 to 87.1	1.6 Percentage of participants Interval 0.0 to 8.8	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 29	95.8 Percentage of participants Interval 88.3 to 99.1	97.2 Percentage of participants Interval 90.3 to 99.7	95.8 Percentage of participants Interval 88.3 to 99.1	97.3 Percentage of participants Interval 97.3 to 99.7	0.0 Percentage of participants Interval 0.0 to 4.9	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 87	97.0 Percentage of participants Interval 89.6 to 99.6	97.0 Percentage of participants Interval 89.5 to 99.6	96.9 Percentage of participants Interval 89.2 to 99.6	98.6 Percentage of participants Interval 92.4 to 100.0	1.5 Percentage of participants Interval 0.0 to 7.9	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 114	98.5 Percentage of participants Interval 91.8 to 100.0	97.0 Percentage of participants Interval 89.6 to 99.6	98.4 Percentage of participants Interval 91.6 to 100.0	98.6 Percentage of participants Interval 92.4 to 100.0	1.5 Percentage of participants Interval 0.0 to 7.9	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With Antibodies Binding to SARS-CoV-2 S Protein as Measured by Enzyme-linked Immunosorbent Assay (ELISA) Day 268	98.3 Percentage of participants Interval 91.1 to 100.0	85.5 Percentage of participants Interval 73.3 to 93.5	100.0 Percentage of participants Interval 93.3 to 100.0	87.7 Percentage of participants Interval 76.3 to 94.9	16.7 Percentage of participants Interval 0.4 to 64.1	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29, 57, 71, 85, 239 and 422

Population: PPI population was analyzed. 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=22 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=24 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=24 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=25 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 29	233 Titers Interval 170.0 to 319.0	224 Titers Interval 158.0 to 319.0	333 Titers Interval 206.0 to 537.0	219 Titers Interval 170.0 to 282.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 57	310 Titers Interval 232.0 to 414.0	284 Titers Interval 220.0 to 367.0	458 Titers Interval 309.0 to 677.0	392 Titers Interval 273.0 to 563.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 71	862 Titers Interval 666.0 to 1115.0	294 Titers Interval 229.0 to 378.0	1189 Titers Interval 845.0 to 1672.0	414 Titers Interval 310.0 to 553.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 85	919 Titers Interval 727.0 to 1161.0	317 Titers Interval 217.0 to 463.0	1127 Titers Interval 801.0 to 1587.0	422 Titers Interval 305.0 to 584.0	NA Titers Data could not be estimated as the value was below the LLOQ (61).	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 239	465 Titers Interval 338.0 to 641.0	215 Titers Interval 146.0 to 317.0	771 Titers Interval 514.0 to 1154.0	408 Titers Interval 232.0 to 716.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 422	328 Titers Interval 202.0 to 531.0	235 Titers Interval 132.0 to 418.0	425 Titers Interval 294.0 to 613.0	307 Titers Interval 205.0 to 460.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29, 183, 190, 211, 366, 373 and 394

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 2b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=51 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=26 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=15 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 29	311 Titers Interval 235.0 to 411.0	326 Titers Interval 258.0 to 411.0	369 Titers Interval 251.0 to 542.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 183	241 Titers Interval 179.0 to 324.0	379 Titers Interval 214.0 to 672.0	172 Titers Interval 107.0 to 277.0	833 Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 190	208 Titers Interval 149.0 to 290.0	1576 Titers Interval 976.0 to 2544.0	162 Titers Interval 88.0 to 301.0	961 Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 211	216 Titers Interval 150.0 to 311.0	2035 Titers Interval 1202.0 to 3446.0	157 Titers Interval 96.0 to 256.0	486 Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 366	224 Titers Interval 131.0 to 383.0	1137 Titers Interval 661.0 to 1955.0	124 Titers Interval 60.0 to 258.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 373	245 Titers Interval 138.0 to 435.0	1248 Titers Interval 566.0 to 2753.0	973 Titers Interval 240.0 to 3954.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 394	297 Titers Interval 152.0 to 581.0	1387 Titers Interval 612.0 to 3143.0	3061 Titers Interval 141.0 to Upper limit of 95% CI could not be estimated as the value was above the upper limit of quantification (ULOQ) (12800).	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

GMTs of SARS-CoV-2 neutralizing antibodies to the Wild-type VNA were reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=24 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=25 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=22 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 29	267 Titers Interval 183.0 to 389.0	229 Titers Interval 152.0 to 346.0	261 Titers Interval 168.0 to 406.0	174 Titers Interval 131.0 to 233.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 87	224 Titers Interval 134.0 to 375.0	165 Titers Interval 114.0 to 238.0	245 Titers Interval 174.0 to 346.0	198 Titers Interval 126.0 to 309.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 100	878 Titers Interval 521.0 to 1478.0	168 Titers Interval 106.0 to 266.0	574 Titers Interval 367.0 to 897.0	178 Titers Interval 97.0 to 329.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 15	190 Titers Interval 100.0 to 360.0	153 Titers Interval 90.0 to 261.0	209 Titers Interval 121.0 to 361.0	140 Titers Interval 70.0 to 280.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 114	954 Titers Interval 551.0 to 1652.0	164 Titers Interval 98.0 to 273.0	895 Titers Interval 498.0 to 1609.0	158 Titers Interval 78.0 to 319.0	NA Titers Data could not be estimated as the value was below the LLOQ (58).	—	—	—	—	—	—	—	—	—	—
Cohort 3: Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Antibodies to the Wild Type Virus as Measured by Virus Neutralization Assay (VNA) Day 268	—	114 Titers Interval 65.0 to 201.0	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 15, 29, 57, 71, 85, 239 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=37 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 239	47 Percentage of participants Interval 30.0 to 65.0	47 Percentage of participants Interval 30.0 to 65.0	75 Percentage of participants Interval 43.0 to 95.0	38 Percentage of participants Interval 14.0 to 68.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Baseline	8 Percentage of participants Interval 2.0 to 22.0	8 Percentage of participants Interval 2.0 to 21.0	0 Percentage of participants Interval 0.0 to 10.0	3 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 15	76 Percentage of participants Interval 59.0 to 88.0	76 Percentage of participants Interval 60.0 to 89.0	83 Percentage of participants Interval 67.0 to 94.0	82 Percentage of participants Interval 65.0 to 93.0	8 Percentage of participants Interval 2.0 to 21.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 29	73 Percentage of participants Interval 56.0 to 86.0	70 Percentage of participants Interval 53.0 to 84.0	78 Percentage of participants Interval 61.0 to 90.0	72 Percentage of participants Interval 53.0 to 86.0	19 Percentage of participants Interval 8.0 to 35.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 57	75 Percentage of participants Interval 58.0 to 88.0	53 Percentage of participants Interval 35.0 to 70.0	77 Percentage of participants Interval 60.0 to 90.0	63 Percentage of participants Interval 44.0 to 80.0	12 Percentage of participants Interval 3.0 to 28.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 71	63 Percentage of participants Interval 45.0 to 79.0	47 Percentage of participants Interval 30.0 to 65.0	91 Percentage of participants Interval 76.0 to 98.0	61 Percentage of participants Interval 41.0 to 79.0	16 Percentage of participants Interval 5.0 to 33.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 85	68 Percentage of participants Interval 50.0 to 82.0	46 Percentage of participants Interval 29.0 to 63.0	85 Percentage of participants Interval 68.0 to 95.0	59 Percentage of participants Interval 39.0 to 76.0	12 Percentage of participants Interval 3.0 to 27.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 422	27 Percentage of participants Interval 11.0 to 50.0	43 Percentage of participants Interval 23.0 to 66.0	54 Percentage of participants Interval 25.0 to 81.0	36 Percentage of participants Interval 11.0 to 69.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29 and 366

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Baseline	9 Percentage of participants Interval 0.0 to 41.0	20 Percentage of participants Interval 1.0 to 72.0	0 Percentage of participants Interval 0.0 to 52.0	33 Percentage of participants Interval 1.0 to 91.0	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 29	82 Percentage of participants Interval 48.0 to 98.0	100 Percentage of participants Interval 48.0 to 100.0	80 Percentage of participants Interval 28.0 to 99.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Cohorts 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 366	11 Percentage of participants Interval 0.0 to 48.0	20 Percentage of participants Interval 1.0 to 72.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29, 57, 85 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=12 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Baseline	25 Percentage of participants Interval 5.0 to 57.0	20 Percentage of participants Interval 1.0 to 72.0	17 Percentage of participants Interval 0.0 to 64.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 29	82 Percentage of participants Interval 48.0 to 98.0	40 Percentage of participants Interval 5.0 to 85.0	67 Percentage of participants Interval 22.0 to 96.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 57	75 Percentage of participants Interval 43.0 to 95.0	80 Percentage of participants Interval 28.0 to 99.0	40 Percentage of participants Interval 5.0 to 85.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 85	60 Percentage of participants Interval 26.0 to 88.0	80 Percentage of participants Interval 28.0 to 99.0	50 Percentage of participants Interval 12.0 to 88.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: Interferon Gamma (IFNg)+ or Interleukin 2+ (IL2+) Not Helper Cell Type 2 (TH2) Day 422	0 Percentage of participants Interval 0.0 to 98.0	0 Percentage of participants Interval 0.0 to 98.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell Responses for IFNg+ or IL2+ not Helper cell type 2 (TH2) was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=38 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=34 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=41 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Baseline	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	3 Percentage of participants Interval 0.0 to 16.0	0 Percentage of participants Interval 0.0 to 9.0	6 Percentage of participants Interval 1.0 to 19.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 15	61 Percentage of participants Interval 43.0 to 76.0	63 Percentage of participants Interval 45.0 to 79.0	67 Percentage of participants Interval 48.0 to 82.0	62 Percentage of participants Interval 45.0 to 77.0	6 Percentage of participants Interval 1.0 to 19.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 29	66 Percentage of participants Interval 49.0 to 80.0	69 Percentage of participants Interval 52.0 to 84.0	68 Percentage of participants Interval 49.0 to 83.0	76 Percentage of participants Interval 60.0 to 88.0	14 Percentage of participants Interval 5.0 to 30.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 87	42 Percentage of participants Interval 25.0 to 61.0	48 Percentage of participants Interval 29.0 to 68.0	39 Percentage of participants Interval 20.0 to 61.0	52 Percentage of participants Interval 34.0 to 69.0	4 Percentage of participants Interval 0.0 to 20.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 100	61 Percentage of participants Interval 42.0 to 77.0	61 Percentage of participants Interval 42.0 to 77.0	78 Percentage of participants Interval 58.0 to 91.0	58 Percentage of participants Interval 41.0 to 74.0	3 Percentage of participants Interval 0.0 to 17.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 114	71 Percentage of participants Interval 53.0 to 85.0	69 Percentage of participants Interval 50.0 to 84.0	69 Percentage of participants Interval 49.0 to 85.0	44 Percentage of participants Interval 28.0 to 62.0	17 Percentage of participants Interval 6.0 to 36.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IFNg+ or IL2+ Not Helper Cell Type 2 (TH2) Day 268	59 Percentage of participants Interval 39.0 to 76.0	73 Percentage of participants Interval 52.0 to 88.0	40 Percentage of participants Interval 12.0 to 74.0	57 Percentage of participants Interval 29.0 to 82.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Day 15, 29, 57, 71, 85, 239 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=37 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Baseline	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 15	0 Percentage of participants Interval 0.0 to 9.0	3 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 29	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 9.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 57	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 12.0	6 Percentage of participants Interval 1.0 to 20.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 71	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	4 Percentage of participants Interval 0.0 to 18.0	0 Percentage of participants Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 85	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 10.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 239	3 Percentage of participants Interval 0.0 to 15.0	6 Percentage of participants Interval 1.0 to 20.0	17 Percentage of participants Interval 2.0 to 48.0	0 Percentage of participants Interval 0.0 to 25.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 422	5 Percentage of participants Interval 0.0 to 23.0	4 Percentage of participants Interval 0.0 to 22.0	0 Percentage of participants Interval 0.0 to 25.0	9 Percentage of participants Interval 0.0 to 41.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29 and 366

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Baseline	0 Percentage of participants Interval 0.0 to 28.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 29	0 Percentage of participants Interval 0.0 to 28.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 366	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29, 57, 85 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=12 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Baseline	0 Percentage of participants Interval 0.0 to 26.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 46.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 29	0 Percentage of participants Interval 0.0 to 28.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 46.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 57	0 Percentage of participants Interval 0.0 to 26.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 85	0 Percentage of participants Interval 0.0 to 31.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 46.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 422	0 Percentage of participants Interval 0.0 to 98.0	0 Percentage of participants Interval 0.0 to 98.0	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD4+ T-cell responses for IL4+ and/or (IL5+/IL13+) and CD40L+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=38 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=34 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=41 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 268	7 Percentage of participants Interval 1.0 to 23.0	8 Percentage of participants Interval 1.0 to 25.0	20 Percentage of participants Interval 3.0 to 56.0	7 Percentage of participants Interval 0.0 to 34.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Baseline	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 15	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	3 Percentage of participants Interval 0.0 to 16.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 29	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 10.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 87	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 13.0	4 Percentage of participants Interval 0.0 to 22.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 13.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 100	6 Percentage of participants Interval 1.0 to 20.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 12.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD4+ T-cell Responses: IL4+ and/or (IL5+/IL13+) and CD40L+ Day 114	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 11.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 10.0	0 Percentage of participants Interval 0.0 to 12.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 15, 29, 57, 71, 85, 239 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=37 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Baseline	0 Percentage of participants Interval 0.0 to 9.0	3 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 10.0	3 Percentage of participants Interval 0.0 to 15.0	5 Percentage of participants Interval 1.0 to 17.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 15	54 Percentage of participants Interval 37.0 to 71.0	45 Percentage of participants Interval 29.0 to 62.0	56 Percentage of participants Interval 38.0 to 72.0	71 Percentage of participants Interval 53.0 to 85.0	8 Percentage of participants Interval 2.0 to 21.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 29	68 Percentage of participants Interval 50.0 to 82.0	59 Percentage of participants Interval 42.0 to 75.0	81 Percentage of participants Interval 64.0 to 92.0	75 Percentage of participants Interval 57.0 to 89.0	3 Percentage of participants Interval 0.0 to 14.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 57	72 Percentage of participants Interval 55.0 to 86.0	81 Percentage of participants Interval 64.0 to 92.0	89 Percentage of participants Interval 73.0 to 97.0	83 Percentage of participants Interval 65.0 to 94.0	6 Percentage of participants Interval 1.0 to 20.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 71	68 Percentage of participants Interval 49.0 to 83.0	72 Percentage of participants Interval 55.0 to 86.0	86 Percentage of participants Interval 70.0 to 95.0	79 Percentage of participants Interval 59.0 to 92.0	9 Percentage of participants Interval 2.0 to 25.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 85	73 Percentage of participants Interval 56.0 to 86.0	69 Percentage of participants Interval 51.0 to 83.0	88 Percentage of participants Interval 72.0 to 97.0	83 Percentage of participants Interval 64.0 to 94.0	9 Percentage of participants Interval 2.0 to 24.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 239	62 Percentage of participants Interval 44.0 to 78.0	62 Percentage of participants Interval 44.0 to 78.0	92 Percentage of participants Interval 62.0 to 100.0	85 Percentage of participants Interval 55.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 422	52 Percentage of participants Interval 31.0 to 73.0	57 Percentage of participants Interval 34.0 to 77.0	77 Percentage of participants Interval 46.0 to 95.0	82 Percentage of participants Interval 48.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29 and 366

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=3 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Baseline	0 Percentage of participants Interval 0.0 to 28.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 52.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 29	91 Percentage of participants Interval 59.0 to 100.0	100 Percentage of participants Interval 48.0 to 100.0	100 Percentage of participants Interval 48.0 to 100.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 366	78 Percentage of participants Interval 40.0 to 97.0	75 Percentage of participants Interval 19.0 to 99.0	100 Percentage of participants Interval 29.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 29, 57, 85 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=12 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=2 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Baseline	8 Percentage of participants Interval 0.0 to 38.0	20 Percentage of participants Interval 1.0 to 72.0	0 Percentage of participants Interval 0.0 to 46.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 29	82 Percentage of participants Interval 48.0 to 98.0	80 Percentage of participants Interval 28.0 to 99.0	83 Percentage of participants Interval 36.0 to 100.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 57	92 Percentage of participants Interval 62.0 to 100.0	100 Percentage of participants Interval 48.0 to 100.0	80 Percentage of participants Interval 28.0 to 99.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 85	80 Percentage of participants Interval 44.0 to 97.0	100 Percentage of participants Interval 48.0 to 100.0	83 Percentage of participants Interval 36.0 to 100.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 422	100 Percentage of participants Interval 3.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with SARS-Cov2 S Specific CD8+ T-cell Responses for IFNg+ or IL2+ was reported. Cellular immunogenicity was measured by intracellular cytokine staining (ICS), allowing characterization of individual CD4 and CD8 T cell immune responses to vaccination.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=36 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=35 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=33 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=39 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=33 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Baseline	3 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 10.0	6 Percentage of participants Interval 1.0 to 21.0	0 Percentage of participants Interval 0.0 to 9.0	0 Percentage of participants Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 15	35 Percentage of participants Interval 20.0 to 54.0	23 Percentage of participants Interval 10.0 to 40.0	26 Percentage of participants Interval 12.0 to 45.0	26 Percentage of participants Interval 13.0 to 43.0	3 Percentage of participants Interval 0.0 to 16.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 29	58 Percentage of participants Interval 41.0 to 74.0	51 Percentage of participants Interval 34.0 to 69.0	52 Percentage of participants Interval 34.0 to 69.0	64 Percentage of participants Interval 47.0 to 79.0	0 Percentage of participants Interval 0.0 to 11.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 87	59 Percentage of participants Interval 39.0 to 76.0	58 Percentage of participants Interval 37.0 to 77.0	45 Percentage of participants Interval 24.0 to 68.0	71 Percentage of participants Interval 52.0 to 86.0	0 Percentage of participants Interval 0.0 to 15.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 100	65 Percentage of participants Interval 45.0 to 81.0	52 Percentage of participants Interval 34.0 to 69.0	65 Percentage of participants Interval 44.0 to 83.0	67 Percentage of participants Interval 49.0 to 81.0	0 Percentage of participants Interval 0.0 to 13.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 114	75 Percentage of participants Interval 57.0 to 89.0	47 Percentage of participants Interval 29.0 to 65.0	62 Percentage of participants Interval 41.0 to 80.0	68 Percentage of participants Interval 49.0 to 83.0	0 Percentage of participants Interval 0.0 to 13.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With SARS-Cov2 S Specific CD8+ T-cell Responses: IFNg+ or IL2+ Day 268	57 Percentage of participants Interval 37.0 to 76.0	50 Percentage of participants Interval 30.0 to 70.0	78 Percentage of participants Interval 40.0 to 97.0	71 Percentage of participants Interval 42.0 to 92.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 15, 29, 57, 71, 85, 239 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to the change in planned analysis, data was not collected and analyzed for Cohort 1b and thus no data was reported for this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=27 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=29 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=28 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=6 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 85: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 22.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 21.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 239: Th1/Th2 >=1	100 Percentage of participants Interval 78.0 to 100.0	100 Percentage of participants Interval 79.0 to 100.0	100 Percentage of participants Interval 66.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 239: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 22.0	0 Percentage of participants Interval 0.0 to 21.0	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 422: Th1/Th2 >=1	86 Percentage of participants Interval 42.0 to 100.0	100 Percentage of participants Interval 69.0 to 100.0	100 Percentage of participants Interval 59.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 422: Th1/Th2 <1	14 Percentage of participants Interval 0.0 to 58.0	0 Percentage of participants Interval 0.0 to 31.0	0 Percentage of participants Interval 0.0 to 41.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 15: Th1/Th2 >=1	100 Percentage of participants Interval 87.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 29.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 15: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 >=1	100 Percentage of participants Interval 87.0 to 100.0	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 54.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 46.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 57: Th1/Th2 >=1	100 Percentage of participants Interval 87.0 to 100.0	100 Percentage of participants Interval 82.0 to 100.0	100 Percentage of participants Interval 87.0 to 100.0	100 Percentage of participants Interval 82.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 57: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 18.0	0 Percentage of participants Interval 0.0 to 13.0	0 Percentage of participants Interval 0.0 to 18.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 71: Th1/Th2 >=1	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 80.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 80.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 71: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 20.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 20.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—
Cohort 1a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 85: Th1/Th2 >=1	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 78.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 79.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29 and 366

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to change in planned analysis, data was not collected and analyzed for "COHORT 2A: Placebo, B: PL" arm in this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=11 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 >=1	100 Percentage of participants Interval 66.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 60.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 366: Th1/Th2 >=1	100 Percentage of participants Interval 3.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2a: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 366: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 98.0	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 29, 57, 85 and 422

Population: PPI population was analyzed. Here, 'N' (Overall number of participants analyzed) =participants who were evaluable for this outcome measure and "n" (number analyzed) =participants who were evaluable for specified time points. Due to change in planned analysis, data was not collected and analyzed for "COHORT 2B: Placebo, B: PL" arm in this outcome measure. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participants with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=12 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=6 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 >=1	100 Percentage of participants Interval 66.0 to 100.0	100 Percentage of participants Interval 16.0 to 100.0	100 Percentage of participants Interval 29.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 84.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 57: Th1/Th2 >=1	100 Percentage of participants Interval 66.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 57: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 60.0	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 85: Th1/Th2 >=1	100 Percentage of participants Interval 54.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	100 Percentage of participants Interval 29.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 85: Th1/Th2 <1	0 Percentage of participants Interval 0.0 to 46.0	0 Percentage of participants Interval 0.0 to 60.0	0 Percentage of participants Interval 0.0 to 71.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 422: Th1/Th2 >=1	—	—	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—	—
Cohort 2b: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 422: Th1/Th2 <1	—	—	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 15, 29, 87, 100, 114 and 268

Population: FAS included all participant with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure and "n" (number analyzed) signifies those participants who were evaluable for specified time points. "0" in the number analyzed field signifies that no participant was available for the analysis at the specified timepoint.

Percentage of participant with Th1 (IFN-g OR IL2 NOT TH2) /Th2 (IL4 OR IL5 OR IL13 AND CD40L) ratio \>=1 and \<1 was reported.

Outcome measures

Outcome measures
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=25 Participants Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=25 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=23 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=30 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=5 Participants Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 100: Th1/Th2 ratio >=1	100 Percentage of participants Interval 83.0 to 100.0	100 Percentage of participants Interval 82.0 to 100.0	100 Percentage of participants Interval 84.0 to 100.0	100 Percentage of participants Interval 84.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 268: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 21.0	6 Percentage of participants Interval 0.0 to 27.0	20 Percentage of participants Interval 1.0 to 72.0	11 Percentage of participants Interval 0.0 to 48.0	—	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 15: Th1/Th2 ratio >=1	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 16.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 15: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 84.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 ratio >=1	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 85.0 to 100.0	100 Percentage of participants Interval 88.0 to 100.0	100 Percentage of participants Interval 40.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 29: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 15.0	0 Percentage of participants Interval 0.0 to 12.0	0 Percentage of participants Interval 0.0 to 60.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 87: Th1/Th2 ratio >=1	100 Percentage of participants Interval 75.0 to 100.0	100 Percentage of participants Interval 74.0 to 100.0	100 Percentage of participants Interval 66.0 to 100.0	100 Percentage of participants Interval 80.0 to 100.0	100 Percentage of participants Interval 3.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 87: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 25.0	0 Percentage of participants Interval 0.0 to 26.0	0 Percentage of participants Interval 0.0 to 34.0	0 Percentage of participants Interval 0.0 to 20.0	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 100: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 17.0	0 Percentage of participants Interval 0.0 to 18.0	0 Percentage of participants Interval 0.0 to 16.0	0 Percentage of participants Interval 0.0 to 16.0	0 Percentage of participants Interval 0.0 to 98.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 114: Th1/Th2 ratio >=1	100 Percentage of participants Interval 86.0 to 100.0	100 Percentage of participants Interval 83.0 to 100.0	100 Percentage of participants Interval 83.0 to 100.0	100 Percentage of participants Interval 79.0 to 100.0	100 Percentage of participants Interval 48.0 to 100.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 114: Th1/Th2 ratio <1	0 Percentage of participants Interval 0.0 to 14.0	0 Percentage of participants Interval 0.0 to 17.0	0 Percentage of participants Interval 0.0 to 17.0	0 Percentage of participants Interval 0.0 to 21.0	0 Percentage of participants Interval 0.0 to 52.0	—	—	—	—	—	—	—	—	—	—
Cohort 3: Percentage of Participants With T Helper Cell 1/T Helper Cell 2 Ratio (Th1/Th2) Greater Than or Equal to (>=) 1 and Less Than (<) 1 Day 268: Th1/Th2 ratio >=1	100 Percentage of participants Interval 79.0 to 100.0	94 Percentage of participants Interval 73.0 to 100.0	80 Percentage of participants Interval 28.0 to 99.0	89 Percentage of participants Interval 52.0 to 100.0	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 64 other events

Deaths: 0 deaths

COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 69 other events

Deaths: 0 deaths

COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 66 other events

Deaths: 0 deaths

COHORT 1A: Placebo, Placebo

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

COHORT 1B: Placebo, Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10

Serious events: 1 serious events

Other events: 27 other events

Deaths: 1 deaths

COHORT 2A: Placebo, B: Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 59 other events

Deaths: 1 deaths

COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

COHORT 2B: Placebo, B: PL

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10)

Serious events: 3 serious events

Other events: 63 other events

Deaths: 0 deaths

COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10)

Serious events: 2 serious events

Other events: 55 other events

Deaths: 2 deaths

COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10)

Serious events: 2 serious events

Other events: 69 other events

Deaths: 0 deaths

COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10)

Serious events: 1 serious events

Other events: 61 other events

Deaths: 1 deaths

COHORT 3: Placebo, Placebo

Serious events: 2 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 participants at risk Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=58 participants at risk Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL n=29 participants at risk Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.	COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 n=32 participants at risk Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\10\^10 vp after 12 months as Booster 2.	COHORT 2A: Placebo, B: Placebo n=17 participants at risk Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=62 participants at risk Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL n=30 participants at risk Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2).	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 n=28 participants at risk Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.	COHORT 2B: Placebo, B: PL n=15 participants at risk Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo n=81 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Cardiac disorders Atrial Fibrillation	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Cardiac disorders Coronary Artery Disease	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/82 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Ear and labyrinth disorders Aural Polyp	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Hanging	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.6% 1/62 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Pyrexia	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Immune system disorders Anaphylactic Shock	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.3% 1/30 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Pneumonia Legionella	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Procedural Nausea	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Procedural Vomiting	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Traumatic Fracture	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Investigations Blood Pressure Decreased	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage Ii	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Multiple Sclerosis	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Renal and urinary disorders Nephrolithiasis	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Reproductive system and breast disorders Uterine Prolapse	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.3% 1/30 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/82 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Surgical and medical procedures Mastectomy	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/79 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.

Other adverse events

Other adverse events
Measure	COHORT 1A: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=77 participants at risk Healthy adult participants aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 55 received a single intramuscular (IM) injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster vaccination (AHBV) of Ad26.COV2.S at the dose of 5\10\^10 \>=6 months after Vaccination 2.	COHORT 1A: Ad26 5e10, PL(AHBV: Ad26 5e10) n=75 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=75 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 1A: Ad26 1e11, PL(AHBV: Ad26 5e10) n=73 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1A: Placebo, Placebo n=77 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 1B: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 5e10, PL(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and a matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Ad26 1e11, PL(AHBV: Ad26 5e10) n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S at the dose of 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 1B: Placebo, Placebo n=5 participants at risk Healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 2A: Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=58 participants at risk Group 1 and Group 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by matching placebo at 6 and 12 months as matching Booster (B) 1 and Booster 2 vaccination. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single AHBV of Ad26.COV2.S. 5\10\^10 vp \>=6 months after Vaccination 2.	COHORT 2A: Ad26 5e10, B: Ad26 5e10, PL n=29 participants at risk Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by first booster vaccination with single IM injection of Ad26.COV2.S 5\10\^10 vp booster 1 at 6 months and a matching placebo at 12 months to match second Booster vaccination.	COHORT 2A: Ad26 5e10, B: PL, Ad26 5e10 n=32 participants at risk Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) followed by a matching placebo booster 1 injection after 6 months and Ad26.COV2.S 5\10\^10 vp after 12 months as Booster 2.	COHORT 2A: Placebo, B: Placebo n=17 participants at risk Group 5 subjects received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), 6 months (Booster 1) and 12 months (Booster 2). Subjects who had previously received 1 or more doses of any COVID-19 vaccine received a single ad hoc booster dose of 5\*10\^10 vp Ad26.COV2.S. 6 months after Booster 2 Vaccination.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL(PL/AHBV: Ad26 5e10) n=62 participants at risk Group 1 and 4 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 and 12 months after vaccination 2 as Booster 1 and Booster 2 vaccines. As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 2B: Ad26 5e10, Ad26 5e10, B: Ad26 5e10, PL n=30 participants at risk Group 2 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\*10\^10 vp on Day 1 (Vaccination 1), Day 57 (Vaccination 2) and 6 months after Vaccination 2(Booster 1). At 12 months after vaccination 2, participants received placebo matching to Ad26.COV2.S vaccine (Booster 2).	COHORT 2B: Ad26 5e10, Ad26 5e10, B: PL, Ad26 5e10 n=28 participants at risk Group 3 healthy adult participants aged \>=18 to \<=55 received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2) and matching placebo at 6 months after vaccination 2 as Booster 1 vaccination and Ad26.COV2.S 5\10\^10 vp at 12 months after vaccination 2 as Booster 2 vaccination.	COHORT 2B: Placebo, B: PL n=15 participants at risk Group 5 healthy adult participants aged \>=18 to \<=55 received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (Vaccination 1), Day 57 (Vaccination 2), 8 Month (Booster 1) and 14 months (Booster 2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.	COHORT 3: Ad26 5e10, Ad26 5e10(AHBV: Ad26 5e10) n=81 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 5e10, PL(AHBV: Ad26 5e10) n=80 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 5\10\^10 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, Ad26 1e11(AHBV: Ad26 5e10) n=82 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Ad26 1e11, PL(AHBV: Ad26 5e10) n=79 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of Ad26.COV2.S 1\10\^11 vp on Day 1 (Vaccination 1) and matching placebo on Day 57 (Vaccination 2). As per protocol amendment 15, all eligible participants who had previously received 1 or more doses of any COVID-19 vaccine were offered a single ad hoc booster dose of 5\10\^10 vp Ad26.COV2.S. \>=6 months after Vaccination 2.	COHORT 3: Placebo, Placebo n=81 participants at risk Adult participants (with good or stable health) aged \>=65 years received a single IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1 (vaccination1) and 57 (Vaccination2). As per protocol amendment 10, after unblinding, enrolled participants who had initially received placebo were offered a single dose of 5\*10\^10 vp Ad26.COV2.S.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Vascular disorders Hypertension	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.7% 3/81 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.4% 2/82 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.1% 4/79 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Blood and lymphatic system disorders Leukopenia	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Gastrointestinal disorders Nausea	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.6% 1/62 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/79 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Gastrointestinal disorders Nausea(Solicited)	24.7% 19/77 • Number of events 22 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	29.3% 22/75 • Number of events 27 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	33.3% 25/75 • Number of events 29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	37.0% 27/73 • Number of events 31 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.5% 5/77 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	32.8% 19/58 • Number of events 19 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	27.6% 8/29 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	12.5% 4/32 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	11.8% 2/17 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	35.5% 22/62 • Number of events 27 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	26.7% 8/30 • Number of events 10 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	32.1% 9/28 • Number of events 10 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	13.3% 2/15 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.2% 5/81 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	8.8% 7/80 • Number of events 7 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	13.4% 11/82 • Number of events 11 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	11.4% 9/79 • Number of events 12 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	13.6% 11/81 • Number of events 11 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Chills	3.9% 3/77 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.0% 3/75 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	8.0% 6/75 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	15.1% 11/73 • Number of events 11 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.6% 2/77 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	80.0% 4/5 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.2% 3/58 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.5% 4/62 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 2/30 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/80 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	7.3% 6/82 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	7.6% 6/79 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Fatigue	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.0% 3/75 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.5% 5/77 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 2/58 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	11.8% 2/17 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.2% 2/62 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.3% 1/30 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/80 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.4% 2/82 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Fatigue(Solicited)	64.9% 50/77 • Number of events 72 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	54.7% 41/75 • Number of events 52 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	77.3% 58/75 • Number of events 89 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	72.6% 53/73 • Number of events 63 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	22.1% 17/77 • Number of events 21 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	80.0% 4/5 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	80.0% 4/5 • Number of events 6 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	63.8% 37/58 • Number of events 37 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	58.6% 17/29 • Number of events 17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	46.9% 15/32 • Number of events 15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	41.2% 7/17 • Number of events 7 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	69.4% 43/62 • Number of events 67 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	50.0% 15/30 • Number of events 26 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	67.9% 19/28 • Number of events 30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	26.7% 4/15 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	46.9% 38/81 • Number of events 49 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 32/80 • Number of events 40 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	51.2% 42/82 • Number of events 59 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	49.4% 39/79 • Number of events 48 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	27.2% 22/81 • Number of events 29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Injection Site Haemorrhage	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/82 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/79 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Pyrexia	2.6% 2/77 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/75 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.0% 3/75 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.9% 2/29 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.6% 1/62 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/79 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Pyrexia(Solicited)	16.9% 13/77 • Number of events 14 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	18.7% 14/75 • Number of events 14 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	44.0% 33/75 • Number of events 43 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	38.4% 28/73 • Number of events 29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	25.9% 15/58 • Number of events 15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	10.3% 3/29 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	12.5% 4/32 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	27.4% 17/62 • Number of events 19 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	10.0% 3/30 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	21.4% 6/28 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.2% 5/81 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.8% 3/80 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	8.5% 7/82 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	8.9% 7/79 • Number of events 7 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Vaccination Site Erythema(Solicited)	2.6% 2/77 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.0% 3/75 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 1/29 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.6% 1/62 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	7.1% 2/28 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/80 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/82 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.8% 3/79 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Vaccination Site Pain(Solicited)	75.3% 58/77 • Number of events 99 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	68.0% 51/75 • Number of events 55 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	85.3% 64/75 • Number of events 112 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	82.2% 60/73 • Number of events 66 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	11.7% 9/77 • Number of events 10 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 10 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	80.0% 4/5 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	82.8% 48/58 • Number of events 48 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	79.3% 23/29 • Number of events 23 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	59.4% 19/32 • Number of events 19 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	23.5% 4/17 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	85.5% 53/62 • Number of events 93 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	86.7% 26/30 • Number of events 44 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	71.4% 20/28 • Number of events 36 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 3/15 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	61.7% 50/81 • Number of events 79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 32/80 • Number of events 34 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	67.1% 55/82 • Number of events 83 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	46.8% 37/79 • Number of events 45 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	17.3% 14/81 • Number of events 17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
General disorders Vaccination Site Swelling(Solicited)	3.9% 3/77 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.3% 4/75 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/73 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 1/29 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.2% 2/62 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/81 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.4% 2/82 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/79 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Asymptomatic Bacteriuria	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Ear Lobe Infection	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Oral Herpes	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Rhinitis	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Sinusitis	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/79 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Infections and infestations Upper Respiratory Tract Infection	5.2% 4/77 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.8% 3/79 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.3% 1/30 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/79 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Investigations Haemoglobin Decreased	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Investigations Neutrophil Count Decreased	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Metabolism and nutrition disorders Vitamin D Deficiency	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 1/29 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/81 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.7% 3/82 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/79 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/81 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Back Pain	2.6% 2/77 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/75 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/75 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/73 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.7% 3/82 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/81 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 2/58 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/82 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/81 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Myalgia(Solicited)	40.3% 31/77 • Number of events 48 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	45.3% 34/75 • Number of events 37 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	69.3% 52/75 • Number of events 77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	65.8% 48/73 • Number of events 51 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.2% 4/77 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 7 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	58.6% 34/58 • Number of events 34 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	58.6% 17/29 • Number of events 17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.6% 13/32 • Number of events 13 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	23.5% 4/17 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	51.6% 32/62 • Number of events 51 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	66.7% 20/30 • Number of events 27 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	57.1% 16/28 • Number of events 25 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	13.3% 2/15 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	32.1% 26/81 • Number of events 34 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	22.5% 18/80 • Number of events 23 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	42.7% 35/82 • Number of events 39 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	34.2% 27/79 • Number of events 31 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	14.8% 12/81 • Number of events 13 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/79 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Headache	3.9% 3/77 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.7% 2/75 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.1% 3/73 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.6% 2/77 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.2% 3/58 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.4% 1/29 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.2% 2/62 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 2/30 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/80 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	4.9% 4/82 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.8% 3/79 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.2% 1/81 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Headache(Solicited)	53.2% 41/77 • Number of events 59 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	48.0% 36/75 • Number of events 48 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	69.3% 52/75 • Number of events 79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	74.0% 54/73 • Number of events 64 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	18.2% 14/77 • Number of events 19 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	40.0% 2/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 9 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	100.0% 5/5 • Number of events 5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.0% 3/5 • Number of events 3 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	60.3% 35/58 • Number of events 35 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	55.2% 16/29 • Number of events 16 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	34.4% 11/32 • Number of events 11 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	23.5% 4/17 • Number of events 4 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	69.4% 43/62 • Number of events 69 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	76.7% 23/30 • Number of events 30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	64.3% 18/28 • Number of events 29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	46.7% 7/15 • Number of events 8 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	39.5% 32/81 • Number of events 43 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	33.8% 27/80 • Number of events 32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	47.6% 39/82 • Number of events 58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	35.4% 28/79 • Number of events 41 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	25.9% 21/81 • Number of events 27 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Migraine	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/77 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Paraesthesia	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.3% 1/75 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Presyncope	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.9% 2/29 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.1% 1/32 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	3.6% 1/28 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Nervous system disorders Sinus Headache	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Reproductive system and breast disorders Uterine Spasm	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/73 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	20.0% 1/5 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/58 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/17 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/15 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/80 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/75 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.4% 1/73 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/77 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/5 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	1.7% 1/58 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/29 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/32 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	5.9% 1/17 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/62 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/30 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/28 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	6.7% 1/15 • Number of events 1 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	2.5% 2/80 • Number of events 2 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/82 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/79 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.	0.00% 0/81 • Cohorts 1, 2a and 3: From Day 1 up to 808 days; Cohort 2b: Day 1 up to 752 days FAS included all subjects with at least one vaccine administration documented.

Additional Information

Clinical Franchise 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