Trial Outcomes & Findings for A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents (NCT NCT04535453)

NCT ID: NCT04535453

Last Updated: 2023-06-22

Results Overview

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (\<=LLOQ) and the post-baseline sample was greater than (\>) LLOQ. 2) The baseline sample value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to \[\>=\] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 635 participants
• Primary outcome timeframe: 28 days after Vaccination 2 (Day 85)
• Results posted on: 2023-06-22

Participant Flow

A total of 635 participants were randomized, of which 617 were vaccinated and included in the analysis. As planned, combined data of Adolescents Groups A and B was collected and reported throughout the study.

Participant milestones

Measure	Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval.	Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 8: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group A and B Combined: Ad26.COV2.S 2.5*10^10 Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B.	Group C: Placebo Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp.
Overall Study STARTED	86	81	75	74	81	26	56	27	53	25	30	3
Overall Study COMPLETED	82	73	70	70	75	24	54	25	50	23	30	2
Overall Study NOT COMPLETED	4	8	5	4	6	2	2	2	3	2	0	1

Reasons for withdrawal

Measure	Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval.	Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 8: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group A and B Combined: Ad26.COV2.S 2.5*10^10 Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B.	Group C: Placebo Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp.
Overall Study Death	0	1	0	0	0	0	0	0	0	0	0	0
Overall Study Lost to Follow-up	1	1	1	0	3	1	0	0	1	1	0	0
Overall Study Physician Decision	0	0	0	1	0	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	3	6	3	3	2	1	1	1	1	1	0	1
Overall Study Other	0	0	1	0	1	0	1	1	1	0	0	0

Baseline Characteristics

A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents

Baseline characteristics by cohort

Measure	Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=86 Participants Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6: Placebo, Placebo, Placebo n=26 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval.	Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=56 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 8: Placebo, Placebo, Placebo n=27 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group A and B Combined: Ad26.COV2.S 2.5*10^10 n=30 Participants Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B.	Group C: Placebo n=3 Participants Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp.	Total n=617 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 18.12 • n=5 Participants	49.1 years STANDARD_DEVIATION 19.44 • n=7 Participants	49.2 years STANDARD_DEVIATION 17.33 • n=5 Participants	50.3 years STANDARD_DEVIATION 17.1 • n=4 Participants	48.6 years STANDARD_DEVIATION 18.5 • n=21 Participants	48.4 years STANDARD_DEVIATION 16.88 • n=8 Participants	48.8 years STANDARD_DEVIATION 17.15 • n=8 Participants	49.0 years STANDARD_DEVIATION 17.63 • n=24 Participants	48.1 years STANDARD_DEVIATION 18.99 • n=42 Participants	52.4 years STANDARD_DEVIATION 13.63 • n=42 Participants	16.3 years STANDARD_DEVIATION 0.47 • n=42 Participants	16.3 years STANDARD_DEVIATION 0.58 • n=42 Participants	47.4 years STANDARD_DEVIATION 18.81 • n=36 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
Age, Customized Adolescents (16-17 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	30 Participants n=42 Participants	3 Participants n=42 Participants	33 Participants n=36 Participants
Age, Customized Adults (18-64 years)	57 Participants n=5 Participants	48 Participants n=7 Participants	52 Participants n=5 Participants	48 Participants n=4 Participants	51 Participants n=21 Participants	16 Participants n=8 Participants	37 Participants n=8 Participants	17 Participants n=24 Participants	33 Participants n=42 Participants	16 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	375 Participants n=36 Participants
Age, Customized From 65 to 84 years	29 Participants n=5 Participants	33 Participants n=7 Participants	23 Participants n=5 Participants	26 Participants n=4 Participants	30 Participants n=21 Participants	10 Participants n=8 Participants	19 Participants n=8 Participants	10 Participants n=24 Participants	20 Participants n=42 Participants	9 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	209 Participants n=36 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
Sex: Female, Male Female	26 Participants n=5 Participants	30 Participants n=7 Participants	22 Participants n=5 Participants	32 Participants n=4 Participants	35 Participants n=21 Participants	13 Participants n=8 Participants	14 Participants n=8 Participants	10 Participants n=24 Participants	19 Participants n=42 Participants	13 Participants n=42 Participants	20 Participants n=42 Participants	2 Participants n=42 Participants	236 Participants n=36 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	51 Participants n=7 Participants	53 Participants n=5 Participants	42 Participants n=4 Participants	46 Participants n=21 Participants	13 Participants n=8 Participants	42 Participants n=8 Participants	17 Participants n=24 Participants	34 Participants n=42 Participants	12 Participants n=42 Participants	10 Participants n=42 Participants	1 Participants n=42 Participants	381 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	22 Participants n=7 Participants	20 Participants n=5 Participants	20 Participants n=4 Participants	22 Participants n=21 Participants	8 Participants n=8 Participants	14 Participants n=8 Participants	6 Participants n=24 Participants	9 Participants n=42 Participants	6 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	149 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=5 Participants	56 Participants n=7 Participants	51 Participants n=5 Participants	51 Participants n=4 Participants	58 Participants n=21 Participants	17 Participants n=8 Participants	40 Participants n=8 Participants	18 Participants n=24 Participants	41 Participants n=42 Participants	18 Participants n=42 Participants	29 Participants n=42 Participants	2 Participants n=42 Participants	442 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	26 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 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	2 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	1 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	0 Participants n=42 Participants	0 Participants n=42 Participants	6 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	76 Participants n=7 Participants	71 Participants n=5 Participants	73 Participants n=4 Participants	79 Participants n=21 Participants	25 Participants n=8 Participants	55 Participants n=8 Participants	27 Participants n=24 Participants	53 Participants n=42 Participants	24 Participants n=42 Participants	29 Participants n=42 Participants	3 Participants n=42 Participants	598 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 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	1 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	1 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	6 Participants n=36 Participants

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 85)

Population: Per protocol immunogenicity (PPI) set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (positive PCR test or N-serology) after screening were excluded from analysis. N(Overall number of participants analyzed) signifies participants evaluated for this outcome measure(OM).

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was less than or equal to the lower limit of quantification (<=LLOQ) and the post-baseline sample was greater than (>) LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (greater than or equal to [>=] 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were 50 percent (%) inhibitory concentration (IC50) of 58 and 12,800 international unit per milliliter (IU/mL) respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=36 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=36 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers at 28 Days After Vaccination 2	96.8 Percentage of participants 95% Confidence Interval 83.3 • Interval 83.3 to 99.9	100.0 Percentage of participants 95% Confidence Interval 90.3 • Interval 90.3 to 100.0	88.9 Percentage of participants 95% Confidence Interval 73.9 • Interval 73.9 to 96.9	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 85)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=67 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=60 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1, 2 and 3: Percentage of Participants With Serological Response to Vaccination as Measured by Spike Binding Antibodies Enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days After Vaccination 2	100.0 Percentage of participants 95% Confidence Interval 94.7 • Interval 94.7 to 100.0	100.0 Percentage of participants 95% Confidence Interval 94.6 • Interval 94.6 to 100.0	96.7 Percentage of participants 95% Confidence Interval 88.5 • Interval 88.5 to 99.6	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 85)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=32 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=36 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=37 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Titers (GMTs) as Measured by VNA at 28 Days After Vaccination 2	455 Titer 95% Confidence Interval 321 • Interval 321.0 to 645.0	490 Titer 95% Confidence Interval 376 • Interval 376.0 to 637.0	364 Titer 95% Confidence Interval 239 • Interval 239.0 to 556.0	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 85)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=71 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=60 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1, 2 and 3: Antibody Geometric Mean Concentrations (GMCs) as Measured by (S-ELISA) at 28 Days After Vaccination 2	1742 ELISA unit per milliliter (EU/mL) 95% Confidence Interval 1400 • Interval 1400.0 to 2168.0	1563 ELISA unit per milliliter (EU/mL) 95% Confidence Interval 1273 • Interval 1273.0 to 1918.0	1130 ELISA unit per milliliter (EU/mL) 95% Confidence Interval 802 • Interval 802.0 to 1593.0	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=37 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=34 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=14 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers at 28 Days After Vaccination 1	97.3 Percentage of participants 95% Confidence Interval 85.8 • Interval 85.8 to 99.9	100.0 Percentage of participants 95% Confidence Interval 89.7 • Interval 89.7 to 100.0	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 23.2	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=65 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=65 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=19 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 4, 5 and 6: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 1	98.5 Percentage of participants 95% Confidence Interval 91.7 • Interval 91.7 to 100.0	95.4 Percentage of participants 95% Confidence Interval 87.1 • Interval 87.1 to 99.0	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 17.6	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMTs as measured by VNA at 28 days after vaccination 1 were reported. LLOQ was 58 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=37 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=35 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=14 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 4, 5 and 6: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1	263 Titer Interval 201.0 to 345.0	253 Titer Interval 207.0 to 308.0	NA Titer Geometric mean' and 95% 'confidence interval' could not be estimated as the analyzed values were below the LLOQ.	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 1 were reported. The LLOQ was 50.3 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=66 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=65 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=19 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 4, 5 and 6: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1	505 EU/mL Interval 415.0 to 614.0	360 EU/mL Interval 276.0 to 471.0	NA EU/mL Geometric mean' and 95% 'confidence interval' could not be estimated as the analyzed values were below the LLOQ	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 ( Day 113)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=35 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=13 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 9 and 10: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 2	100.0 Percentage of participants 95% Confidence Interval 90.0 • Interval 90.0 to 100.0	15.4 Percentage of participants 95% Confidence Interval 1.9 • Interval 1.9 to 45.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 113)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participant with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=46 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=23 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 9 and 10: Percentage of Participant With Serological Response to Vaccination as Measured by S-ELISA at 28 Days After Vaccination 2	100.0 Percentage of participants 95% Confidence Interval 92.3 • Interval 92.3 to 100.0	4.3 Percentage of participants 95% Confidence Interval 0.1 • Interval 0.1 to 21.9	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 days after Vaccination 2 (Day 113)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMTs as measured by VNA at 28 days after Vaccination 2 were reported. The LLOQ was 58 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=35 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=13 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 9 and 10: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 2	901 Titer Interval 686.0 to 1185.0	NA Titer Geometric mean' and 95%'confidence interval' could not be estimated as the analyzed values were below the LLOQ.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 Days after Vaccination 2 (Day 113)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMCs as measured by S-ELISA at 28 days after Vaccination 2 were reported. The LLOQ was 50.3 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=46 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=23 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 9 and 10: Antibody GMCs as Measured by S-ELISA at 28 Days After Vaccination 2	2391 EU/mL Interval 1811.0 to 3156.0	NA EU/mL 'Geometric mean' and 95% 'confidence interval' could not be estimated as the analyzed values were below the LLOQ.	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 was reported.

Number of participants with solicited local AEs at 7 days after vaccination 1 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 AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Vaccination 1	27 Participants	24 Participants	39 Participants	42 Participants	21 Participants	2 Participants	75 Participants	7 Participants

PRIMARY outcome

Timeframe: 7 days after Vaccination 1 (Day 8)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Number of participants with solicited systemic AEs at 7 days after vaccination 1 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Vaccination 1	35 Participants	31 Participants	56 Participants	50 Participants	32 Participants	10 Participants	84 Participants	18 Participants

PRIMARY outcome

Timeframe: 7 days after Vaccination 2 (Day 64 for Groups 1-6; Day 92 for Groups 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Number of participants with solicited local AEs at 7 days after vaccination 2 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 AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 2 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 2	33 Participants	29 Participants	5 Participants	4 Participants	20 Participants	2 Participants	63 Participants	3 Participants

PRIMARY outcome

Timeframe: 7 days after Vaccination 2 (Day 64 for Group 1-6; Day 92 for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Number of participants with solicited systemic AEs at 7 days after vaccination 2 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 2 (Day of vaccination 2 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 2	32 Participants	25 Participants	24 Participants	20 Participants	26 Participants	6 Participants	81 Participants	14 Participants

PRIMARY outcome

Timeframe: 28 days after Vaccination 1 (Day 29)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1	25 Participants	15 Participants	33 Participants	30 Participants	8 Participants	5 Participants	39 Participants	9 Participants

PRIMARY outcome

Timeframe: 28 days After Vaccination 2 (Day 85 for Groups 1-6; Day 113 for Groups 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 2	17 Participants	15 Participants	16 Participants	22 Participants	10 Participants	4 Participants	34 Participants	9 Participants

PRIMARY outcome

Timeframe: Up to 1.5 years

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Serious Adverse Events (SAEs)	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	7 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 1.5 years

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is 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/micro liter.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=37 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=26 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=37 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=44 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=19 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=9 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=141 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=52 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: 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

PRIMARY outcome

Timeframe: 7 Days After Vaccination 1 (Day 8)

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

Number of participants with solicited local AEs at 7 days after vaccination 1 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 AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days post vaccination 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=30 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Number of Participants With Solicited Local AEs at 7 Days After Vaccination 1	29 Participants	1 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 7 Days After Vaccination 1 (Day 8)

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

Number of participants with solicited systemic AEs at 7 days after vaccination 1 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days post-vaccination 1 (Day of vaccination1 and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=30 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Number of Participants With Solicited Systemic AEs at 7 Days After Vaccination 1	28 Participants	3 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 28 Days After Vaccination 1 (Day 29)

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

Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=30 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Number of Participants With Unsolicited AEs at 28 Days After Vaccination 1	12 Participants	2 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)

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

SAE was any untoward medical occurrence that at any dose may result in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=30 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Number of Participants With SAEs (Inclusive Multisystem Inflammatory Syndrome in Children [MIS-C])	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to unblinding date / receipt of a new Covid vaccine (Up to 1.5 years)

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

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/micro liter.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=30 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Number of Participants With AESIs	0 Participants	0 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Due to change in planned analysis, data was not collected and analyzed for Group 7 in this outcome measure. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL, respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=25 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=33 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=33 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=32 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1 to 5, Groups 7 and 9: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 7 Days After Antigen Presentation	92.0 Percentage of participants 95% Confidence Interval 74.0 • Interval 74.0 to 99.0	97.0 Percentage of participants 95% Confidence Interval 84.2 • Interval 84.2 to 99.9	83.9 Percentage of participants 95% Confidence Interval 66.3 • Interval 66.3 to 94.5	84.8 Percentage of participants 95% Confidence Interval 68.1 • Interval 68.1 to 94.9	96.3 Percentage of participants 95% Confidence Interval 81.0 • Interval 81.0 to 99.9	—	100.0 Percentage of participants 95% Confidence Interval 89.1 • Interval 89.1 to 100.0	—

SECONDARY outcome

Timeframe: 7 days after antigen presentation (Day 176 for Groups 1-5; Day 148 for Group 7; Day 204 for Group 9)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Due to change in planned analysis, data was not collected and analyzed for Group 7 in this outcome measure. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Antibody GMTs as measured by VNA at 7 days after antigen presentation were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=26 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=33 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=32 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=33 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=28 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=32 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1 to 5, Groups 7 and 9: GMTs as Measured by VNA 7 Days After Antigen Presentation	318 Titer 95% Confidence Interval 207 • Interval 207.0 to 489.0	393 Titer 95% Confidence Interval 272 • Interval 272.0 to 568.0	279 Titer 95% Confidence Interval 171 • Interval 171.0 to 457.0	275 Titer 95% Confidence Interval 182 • Interval 182.0 to 415.0	525 Titer 95% Confidence Interval 339 • Interval 339.0 to 814.0	—	616 Titer 95% Confidence Interval 462 • Interval 462.0 to 822.0	—

SECONDARY outcome

Timeframe: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=62 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=62 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=43 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1 to 5 and Group 9: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	100.0 Percentage of participants 95% Confidence Interval 94.2 • Interval 94.2 to 100.0	100.0 Percentage of participants 95% Confidence Interval 94.2 • Interval 94.2 to 100.0	96.5 Percentage of participants 95% Confidence Interval 87.9 • Interval 87.9 to 99.6	100.0 Percentage of participants 95% Confidence Interval 93.7 • Interval 93.7 to 100.0	91.2 Percentage of participants 95% Confidence Interval 80.7 • Interval 80.7 to 97.1	100.0 Percentage of participants 95% Confidence Interval 91.8 • Interval 91.8 to 100.0	—	—

SECONDARY outcome

Timeframe: Day 148

Population: Modified PPI set included participants who received vaccination 2 within the window (54-64 days).

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL. respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Group 7: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	96.8 Percentage of participants Interval 83.3 to 99.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 Days after Antigen Presentation (Day 176 for Groups 1-5; Day 204 for Group 9)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=65 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=63 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=58 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=58 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=43 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 1 to 5 and Group 9: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation	1146 EU/mL 95% Confidence Interval 904 • Interval 904.0 to 1452.0	1179 EU/mL 95% Confidence Interval 933 • Interval 933.0 to 1490.0	1038 EU/mL 95% Confidence Interval 730 • Interval 730.0 to 1475.0	1024 EU/mL 95% Confidence Interval 721 • Interval 721.0 to 1454.0	1262 EU/mL 95% Confidence Interval 937 • Interval 937.0 to 1702.0	1963 EU/mL 95% Confidence Interval 1514 • Interval 1514.0 to 2545.0	—	—

SECONDARY outcome

Timeframe: Day 148

Population: Modified PPI set included participants who received vaccination 2 within the window (54-64 days).

Antibody GMCs as measured by S-ELISA 7 days after antigen presentation were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Group 7: Antibody GMCs as Measured by S-ELISA 7 Days After Antigen Presentation	1141 EU/mL Interval 721.0 to 1805.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Number of participants with solicited local AEs at 7 days after antigen presentation 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 AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary for 7 days after antigen presentation (day of antigen presentation and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=69 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=47 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=18 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=127 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=44 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Local AEs at 7 Days After Antigen Presentation	28 Participants	29 Participants	31 Participants	35 Participants	16 Participants	2 Participants	50 Participants	1 Participants

SECONDARY outcome

Timeframe: 7 Days After Antigen Presentation (Day 176 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 204 for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Number of participants with solicited systemic AEs at 7 days after antigen presentation 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis for 7 days after antigen presentation (Day of antigen presentation and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree Celsius).

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=69 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=47 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=18 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=127 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=44 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Solicited Systemic AEs at 7 Days After Antigen Presentation	30 Participants	24 Participants	23 Participants	28 Participants	15 Participants	4 Participants	51 Participants	10 Participants

SECONDARY outcome

Timeframe: 28 Days After Antigen Presentation (Day 197 for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 225 for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from Groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with Groups 1 and 6, respectively in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participants diary.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=69 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=47 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=18 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=127 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=44 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With Unsolicited AEs at 28 Days After Antigen Presentation	10 Participants	7 Participants	6 Participants	12 Participants	6 Participants	4 Participants	15 Participants	4 Participants

SECONDARY outcome

Timeframe: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is reported.

SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=69 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=47 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=18 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=127 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=44 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With SAEs After Antigen Presentation	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: After antigen presentation until end of study (Day 170 up to 1.5 years for Groups 2-5, Groups 1 and 7 combined, Groups 6 and 8 combined; Day 198 up to 1.5 years for Group 9 and 10)

Population: FAS included all participants with at least one vaccine administration documented. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Participants from groups 7 and 8 (with vaccination 2 delayed due to pausing rule) were analyzed with groups 1 and 6 in FAS for this OM. Hence, combined data for Groups 1 and 7, and Groups 6 and 8 is 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, is 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/micro liter.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=69 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=68 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=47 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=18 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined n=127 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined n=44 Participants Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 2 to 5, Group 9-10, 1 and 7 Combined, 6 and 8 Combined: Number of Participants With AESIs After Antigen Presentation	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Days 197 and 393

Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=29 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=29 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=26 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=12 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA Day 197	100.0 Percentage of participants Interval 86.8 to 100.0	100.0 Percentage of participants Interval 88.8 to 100.0	96.6 Percentage of participants Interval 82.2 to 99.9	96.8 Percentage of participants Interval 83.3 to 99.9	80.8 Percentage of participants Interval 60.6 to 93.4	0.0 Percentage of participants Interval 0.0 to 26.5	—	—
Adults Groups 1 to 6: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA Day 393	93.1 Percentage of participants Interval 77.2 to 99.2	95.2 Percentage of participants Interval 76.2 to 99.9	84.2 Percentage of participants Interval 60.4 to 96.6	80.0 Percentage of participants Interval 61.4 to 92.3	92.0 Percentage of participants Interval 74.0 to 99.0	—	—	—

SECONDARY outcome

Timeframe: Days 225 and 421

Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Percentage of participants with neutralizing antibody titers to the wild-type SARS-CoV-2 virus expressing S-protein as measured by VNA were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=31 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=10 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA Day 225	100.0 Percentage of participants Interval 88.1 to 100.0	0.0 Percentage of participants Interval 0.0 to 30.8	—	—	—	—	—	—
Adults Group 9 and 10: Percentage of Participants With Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S-protein as Measured by VNA Day 421	100.0 Percentage of participants Interval 88.8 to 100.0	0.0 Percentage of participants Interval 0.0 to 97.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 197 and 393

Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=63 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=60 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=55 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=55 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=56 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=16 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins Day 197	100.0 Percentage of participants Interval 94.2 to 100.0	100.0 Percentage of participants Interval 94.0 to 100.0	98.2 Percentage of participants Interval 90.3 to 100.0	100.0 Percentage of participants Interval 93.5 to 100.0	98.2 Percentage of participants Interval 90.4 to 100.0	0.0 Percentage of participants Interval 0.0 to 20.6	—	—
Adults Groups 1 to 6: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins Day 393	100.0 Percentage of participants Interval 94.3 to 100.0	100.0 Percentage of participants Interval 89.4 to 100.0	85.7 Percentage of participants Interval 67.3 to 96.0	92.2 Percentage of participants Interval 81.1 to 97.8	98.0 Percentage of participants Interval 89.6 to 100.0	—	—	—

SECONDARY outcome

Timeframe: Days 225 and 421

Population: PPI set was analyzed. Here, 'N' (Overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points.

Percentage of participants with binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins were reported.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=39 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=14 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins Day 225	100.0 Percentage of participants Interval 90.5 to 100.0	0.0 Percentage of participants Interval 0.0 to 23.2	—	—	—	—	—	—
Adults of Groups 9 and 10: Percentage of Participants With Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins Day 421	97.4 Percentage of participants Interval 86.5 to 99.9	0.0 Percentage of participants Interval 0.0 to 97.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 Days After Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.

Percentage of participants with serological response to vaccination as measured by VNA titers were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1 (Day 29)	100.0 Percentage of participants 95% Confidence Interval 87.2 • Interval 87.2 to 100.0	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 Days After Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 28 Days After Vaccination 1 (Day 29)	100.0 Percentage of participants 95% Confidence Interval 86.8 • Interval 86.8 to 100.0	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days After Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.

Antibody GMTs as measured by VNA at 28 days after vaccination 1 (Day 29) were reported. LLOQ was 58 IU/mL

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Antibody GMTs as Measured by VNA at 28 Days After Vaccination 1	305 Titer Interval 245.0 to 378.0	NA Titer 'Geometric mean' and 95% confidence interval could not be estimated as the analyzed values were below the LLOQ.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 28 days After Vaccination 1 (Day 29)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis.

Antibody GMCs as measured by S-ELISA 28 days after vaccination was reported. LLOQ was 58 IU/mL

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Antibody GMCs as Measured by S-ELISA 28 Days After Vaccination 1	682 EU/mL Interval 506.0 to 920.0	NA EU/mL "Geometric Mean" and "95% Confidence Interval" data could not be estimated as the analyzed value were below the LLOQ.	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 57, 85 and 169

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. "Number analyzed" signifies participants evaluable at specified time points.

Neutralizing antibody titers to the Wild-type SARS-CoV-2 virus expressing S protein measured by VNA was reported. LLOQ was 58 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA Day 57	323 Titer Interval 262.0 to 399.0	NA Titer "Geometric Mean" and "95% Confidence Interval" data could not be estimated as the analyzed value were below the LLOQ.	—	—	—	—	—	—
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA Day 85	306 Titer Interval 227.0 to 413.0	NA Titer "Geometric Mean" and "95% Confidence Interval" data could not be estimated as the analyzed value were below the LLOQ.	—	—	—	—	—	—
Adolescents: Neutralizing Antibody Titers to the Wild-type SARS-CoV-2 Virus Expressing S Protein as Measured by VNA Day 169	342 Titer Interval 219.0 to 532.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 57, 85, 169

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. "Number analyzed" signifies participants evaluable at specified time points.

Binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 proteins as measured by ELISA was reported. LLOQ was 58 IU/mL.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=27 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=3 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA Day 57	770 Titer Interval 593.0 to 1000.0	NA Titer "Geometric Mean" and "95% Confidence Interval" data could not be estimated as the analyzed value were below the LLOQ.	—	—	—	—	—	—
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA Day 85	773 Titer Interval 547.0 to 1093.0	NA Titer "Geometric Mean" and "95% Confidence Interval" data could not be estimated as the analyzed value were below the LLOQ.	—	—	—	—	—	—
Adolescents: Binding Antibody Titers to SARS-CoV-2 or Individual SARS-CoV-2 Proteins as Measured by ELISA Day 169	796 Titer Interval 449.0 to 1411.0	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 7 Days After Antigen Presentation (Day 176 for Groups 1-5 ; Day 204 for Group 9)

Population: PPI set included all randomized and vaccinated participants with immunogenicity data available excluding participants with major protocol deviations expected to impact immunogenicity outcomes. Samples obtained after missed vaccinations or participants with natural SARS-CoV-2 infection (defined as a positive PCR test or positive N-serology) occurring after screening were excluded from the analysis. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this OM.

Percentage of participants with serological response to vaccination as measured by S-ELISA were reported. A participant was considered a responder if at least one of the following conditions was met: 1) The baseline sample value was <=LLOQ and the post-baseline sample was >LLOQ. 2) The baseline sample value was >LLOQ and the post-baseline sample value represented an at least 4-fold (>= 4-fold) increase from the baseline sample value. The lower limit and upper limit of quantification were IC50 of 58 and 12,800 IU/mL respectively.

Outcome measures

Measure	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=62 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=62 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=57 Participants Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=43 Participants Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Groups 1 and 7 Combined Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 vp on Days 1 and 57 and also received a single antigen presentation IM injection of Ad26.COV2.S at 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6 and 8 Combined Adult participants received IM injection of Ad26.COV2.S vaccine matching placebo on Days 1 and 57 and also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination.
Adults: Percentage of Participants With Serological Response to Vaccination as Measured by S-ELISA 7 Days After Antigen Presentation	100.0 Percentage of participants 95% Confidence Interval 94.2 • Interval 94.2 to 100.0	100.0 Percentage of participants 95% Confidence Interval 94.2 • Interval 94.2 to 100.0	96.5 Percentage of participants 95% Confidence Interval 87.9 • Interval 87.9 to 99.6	100.0 Percentage of participants 95% Confidence Interval 93.7 • Interval 93.7 to 100.0	91.2 Percentage of participants 95% Confidence Interval 80.7 • Interval 80.7 to 97.1	100.0 Percentage of participants 95% Confidence Interval 91.8 • Interval 91.8 to 100.0	—	—

Adverse Events

Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp

Serious events: 7 serious events

Other events: 35 other events

Deaths: 0 deaths

Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp

Serious events: 1 serious events

Other events: 24 other events

Deaths: 1 deaths

Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Group 6: Placebo, Placebo, Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 8: Placebo, Placebo, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Group 10: Placebo, Placebo, Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Group A and B Combined: Ad26.COV2.S 2.5*10^10

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Group C: Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=141 participants at risk Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 participants at risk Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 participants at risk Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 participants at risk Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 participants at risk Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6: Placebo, Placebo, Placebo n=52 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval.	Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=1 participants at risk Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 8: Placebo, Placebo, Placebo n=1 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 participants at risk Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group A and B Combined: Ad26.COV2.S 2.5*10^10 n=30 participants at risk Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B.	Group C: Placebo n=3 participants at risk Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp.
General disorders Pyrexia	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Blood and lymphatic system disorders Pancytopenia	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
General disorders Death	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Hepatobiliary disorders Hepatic Cyst	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.3% 1/75 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Bacteraemia	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Pneumonia	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Systemic Candida	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Injury, poisoning and procedural complications Lower Limb Fracture	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Musculoskeletal and connective tissue disorders Arthropathy	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/53 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.4% 1/74 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Nervous system disorders Cerebrospinal Fluid Leakage	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Nervous system disorders Ischaemic Stroke	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Renal and urinary disorders Haematuria	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.

Other adverse events

Measure	Group 1: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=141 participants at risk Adult participants received 2-dose regimen intramuscular (IM) injection of Ad26.COV2.S vaccine at a dose level of 5\*10\^10 virus particles (vp) on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 2: Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 2.5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=81 participants at risk Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 2.5\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 3: Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=75 participants at risk Adult participants received 2-dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1.25\*10\^10 vp on Days 1 and 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 4: Ad26.COV2.S 1*10^11 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=74 participants at risk Adult participants received single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 1\*10\^11 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 5: Ad26.COV2.S 5*10^10 vp, Placebo, Ad26.COV2.S 1.25*10^10 vp n=81 participants at risk Adult participants received a single dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Day 1 and placebo at Day 57. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 6: Placebo, Placebo, Placebo n=52 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 57. Participants also received a single antigen presentation IM injection with single dose level of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, Adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S 5\*10\^10 vp IM injection vaccine regimen at a 28-day interval.	Group 7: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=1 participants at risk Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 29. Participants also received a single antigen presentation IM injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 8: Placebo, Placebo, Placebo n=1 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 29. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group 9: Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 5*10^10 vp, Ad26.COV2.S 1.25*10^10 vp n=53 participants at risk Adult participants received 2 dose regimen IM injection of Ad26.COV2.S vaccine at dose level of 5\*10\^10 vp on Days 1 and 85. Participants also received a single antigen presentation injection of Ad26.COV2.S 1.25\*10\^10 vp at 4 months after second vaccination.	Group 10: Placebo, Placebo, Placebo n=25 participants at risk Adult participants received IM injection of placebo matching to Ad26.COV2.S vaccine on Days 1 and 85. Participants also received a single antigen presentation IM injection of placebo matching to Ad26.COV2.S at 4 months after second vaccination. With the implementation of Amendment 5, adults who received placebo in the primary vaccine regimen received a 2-dose active Ad26.COV2.S vaccine regimen at a 28-day interval and at a dose level of 5\*10\^10 vp.	Group A and B Combined: Ad26.COV2.S 2.5*10^10 n=30 participants at risk Adolescent participants aged 16 to 17 years received single dose IM injection of Ad26.COV2.S vaccine at a dose level of 2.5\*10\^10 vp on Day 1 in Groups A and B.	Group C: Placebo n=3 participants at risk Adolescent participants aged 16 to 17 years received single dose IM injection of placebo matching to Ad26.COV2.S vaccine on Day 1. At approximately 6 months of study participation, participants were unblinded and received vaccination 1 with Ad26.COV2.S 2.5\*10\^10 vp.
Eye disorders Eye Pain	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	33.3% 1/3 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Gastrointestinal disorders Abdominal Pain	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.7% 3/81 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.3% 1/75 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.4% 1/74 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	8.0% 2/25 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	33.3% 1/3 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
General disorders Chills	3.5% 5/141 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.2% 5/81 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.3% 1/75 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.7% 2/74 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	4.9% 4/81 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/53 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	10.0% 3/30 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
General disorders Fatigue	3.5% 5/141 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.2% 5/81 • Number of events 7 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.7% 2/75 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.4% 4/74 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	7.5% 4/53 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	33.3% 1/3 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Covid-19	2.1% 3/141 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.7% 3/81 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.3% 4/75 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	4.9% 4/81 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	9.6% 5/52 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/53 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	8.0% 2/25 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	23.3% 7/30 • Number of events 8 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Herpes Zoster	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	8.0% 2/25 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Infections and infestations Nasopharyngitis	2.8% 4/141 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.2% 1/81 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	9.3% 7/75 • Number of events 7 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.8% 5/74 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	9.9% 8/81 • Number of events 8 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.8% 2/52 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.8% 2/53 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.7% 2/30 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Musculoskeletal and connective tissue disorders Back Pain	4.3% 6/141 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.5% 2/81 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.7% 2/75 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.4% 4/74 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.2% 5/81 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.8% 2/53 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Nervous system disorders Headache	12.8% 18/141 • Number of events 18 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	13.6% 11/81 • Number of events 17 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	10.7% 8/75 • Number of events 10 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	14.9% 11/74 • Number of events 14 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	18.5% 15/81 • Number of events 19 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	13.5% 7/52 • Number of events 9 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	17.0% 9/53 • Number of events 12 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	24.0% 6/25 • Number of events 9 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Reproductive system and breast disorders Premenstrual Pain	0.00% 0/141 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/75 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/74 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/81 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/52 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/53 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	33.3% 1/3 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 2/141 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.7% 3/81 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.7% 2/75 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	4.1% 3/74 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	2.5% 2/81 • Number of events 2 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	7.5% 4/53 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	2.1% 3/141 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.7% 3/81 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.3% 1/75 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.4% 4/74 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	4.9% 4/81 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.7% 3/53 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	10.0% 3/30 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.71% 1/141 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	3.7% 3/81 • Number of events 3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	6.7% 5/75 • Number of events 6 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	5.4% 4/74 • Number of events 5 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	4.9% 4/81 • Number of events 4 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/52 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	1.9% 1/53 • Number of events 1 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/25 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/30 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.	0.00% 0/3 • Up to 1.5 years FAS included all participants with at least one vaccine administration documented. 55 participants from group 7 and 26 participants from group 8 with vaccination 2 delayed due to study pause were analyzed with groups 1 and 6 respectively. However, 1 participant in group 7 and 1 participant in group 8 received the second vaccination as scheduled (28 days after first vaccination). Therefore, adverse events for these 2 participants were included in Groups 7 and 8 reporting arms.

Additional Information

SENIOR ADVISOR CLINICAL DEVELOPMENT

Janssen Vaccines & Prevention B.V.

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

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