Trial Outcomes & Findings for A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2 (NCT NCT04999111)
NCT ID: NCT04999111
Last Updated: 2025-02-04
Results Overview
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S was reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (\<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (\>=) 4\*LLOQ or (2) Pre-booster titer greater than (\>) LLOQ and post-booster titer \>=4\*pre-booster titer value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1541 participants
Primary outcome timeframe
14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)
Results posted on
2025-02-04
Participant Flow
Participants who received primary vaccination with Ad26.COV2.S and BNT162b2 were enrolled in this study. 1541 participants were enrolled in the study, of which 1532 participants were randomized in the study and vaccinated.
Participant milestones
| Measure |
Cohort 1: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at 5\*10\^10 virus particle (vp) dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
331
|
328
|
116
|
329
|
331
|
106
|
|
Overall Study
Randomized and Vaccinated
|
330
|
326
|
116
|
326
|
328
|
106
|
|
Overall Study
COMPLETED
|
277
|
271
|
96
|
260
|
251
|
84
|
|
Overall Study
NOT COMPLETED
|
54
|
57
|
20
|
69
|
80
|
22
|
Reasons for withdrawal
| Measure |
Cohort 1: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at 5\*10\^10 virus particle (vp) dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
21
|
16
|
2
|
26
|
30
|
6
|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
23
|
29
|
15
|
30
|
35
|
10
|
|
Overall Study
Other
|
6
|
6
|
3
|
8
|
8
|
5
|
|
Overall Study
Non-compliance with study schedule
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Randomized but not vaccinated
|
1
|
2
|
0
|
3
|
3
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Initiated prohibited medication
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Ad26.COV2.S Administered as Booster Vaccination in Adults Who Have Previously Received Primary Vaccination With Ad26.COV2.S or BNT162b2
Baseline characteristics by cohort
| Measure |
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Total
n=1532 Participants
Total of all reporting groups
|
Cohort 1: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at 5\*10\^10 virus particle (vp) dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
47.9 years
STANDARD_DEVIATION 15.12 • n=21 Participants
|
50 years
STANDARD_DEVIATION 17.98 • n=8 Participants
|
51.9 years
STANDARD_DEVIATION 15.5 • n=8 Participants
|
55.4 years
STANDARD_DEVIATION 14.84 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 13.88 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
47.2 years
STANDARD_DEVIATION 15.38 • n=4 Participants
|
|
Age, Customized
Adults (18-64 years)
|
268 Participants
n=21 Participants
|
75 Participants
n=8 Participants
|
1162 Participants
n=8 Participants
|
234 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
275 Participants
n=4 Participants
|
|
Age, Customized
From 65 to 84 years
|
59 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
365 Participants
n=8 Participants
|
94 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Customized
85 years and over
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
815 Participants
n=8 Participants
|
159 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
190 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
717 Participants
n=8 Participants
|
171 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
183 Participants
n=8 Participants
|
38 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
281 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
1298 Participants
n=8 Participants
|
274 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
281 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
51 Participants
n=8 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
68 Participants
n=8 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
102 Participants
n=8 Participants
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
279 Participants
n=21 Participants
|
91 Participants
n=8 Participants
|
1315 Participants
n=8 Participants
|
275 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
292 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
328 Participants
n=21 Participants
|
106 Participants
n=8 Participants
|
1532 Participants
n=8 Participants
|
330 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
326 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)Population: Non-inferiority (NI) analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 original strain (Wuhan, 2019, whole genome sequence) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S was reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer less than (\<) lower limit of quantification (LLOQ) and post-booster titer greater than or equal to (\>=) 4\*LLOQ or (2) Pre-booster titer greater than (\>) LLOQ and post-booster titer \>=4\*pre-booster titer value.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=93 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
|
63.4 Percentage of participants
Interval 57.7 to 68.9
|
57.9 Percentage of participants
Interval 52.1 to 63.6
|
64.5 Percentage of participants
Interval 53.9 to 74.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., on Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with Ad26.COV2.S (5×10\^10 vp dose level) were reported. GMT against original strain was assessed by virus neutralization assay (VNA).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=93 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With Ad26.COV2.S
|
1130 Titer
Interval 989.0 to 1291.0
|
915 Titer
Interval 792.0 to 1058.0
|
734 Titer
Interval 564.0 to 954.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10\^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer \<LLOQ and post-vaccination titer \>=4\*LLOQ or (2) Pre-dose titer \>LLOQ and post-vaccination titer \>=4\*pre-dose 1 titer value.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=312 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=315 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=111 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
|
15.4 Percentage of participants
Interval 11.6 to 19.9
|
16.8 Percentage of participants
Interval 12.9 to 21.4
|
11.7 Percentage of participants
Interval 6.4 to 19.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 28 days after primary vaccination with Ad26.COV2.S (5×10\^10 vp dose level) were reported. GMT against original strain was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=312 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=315 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=112 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 28 Days After Primary Vaccination With Ad26.COV2.S
|
98 Titer
Interval 85.0 to 113.0
|
100 Titer
Interval 87.0 to 115.0
|
76 Titer
Interval to 92.0
Lower limit of 95% CI could not be estimated as it was below the LLOQ (75).
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against leading variant of high consequence or concern (delta variant) 14 days after Ad26.COV2.S booster vaccination (5\*10\^10 vp Dose Level) after completing primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-booster titer \<LLOQ and post-booster titer \>=4\*LLOQ or (2) Pre-booster titer \>LLOQ and post-booster titer \>=4\*pre-booster titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against the Delta Variant 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
|
56.7 Percentage of participants
Interval 50.9 to 62.4
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against leading variant of high consequence or concern (delta variant) 14 days After Ad26.COV2.S booster vaccination (5\*10\^10 vp dose level) after completing primary vaccination with Ad26.COV2.S were reported. GMT against Delta Variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Ad26.COV2.S Booster Vaccination (5*10^10 vp Dose Level) After Completing Primary Vaccination With Ad26.COV2.S
|
471 Titer
Interval 411.0 to 539.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5\*10\^10 vp dose level) were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) Pre-dose titer \<LLOQ and post-vaccination titer \>=4\*LLOQ or (2) Pre-dose titer \>LLOQ and post-vaccination titer \>=4\*pre-dose 1 titer value. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=308 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S
|
8.8 Percentage of participants
Interval 5.9 to 12.5
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days after primary vaccination with Ad26.COV2.S (Day 29 of study VAC31518COV3001)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (delta variant) 28 days after primary vaccination with Ad26.COV2.S (5\*10\^10 vp dose level) were reported. GMT against Delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 1: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants. Lower limit of Quantification (LLOQ) was 65.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=311 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Delta Variant) 28 Days After Primary Vaccination With Ad26.COV2.S (5*10^10 vp Dose Level)
|
NA Titer
Geometric mean and lower limit and upper limit of 95% CI could not be estimated as the lower and upper limit of 95% CI values were below the LLOQ (65).
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 original strain, 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=294 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=88 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
|
97.0 Percentage of participants
Interval 94.3 to 98.6
|
90.5 Percentage of participants
Interval 86.5 to 93.6
|
89.8 Percentage of participants
Interval 81.5 to 95.2
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 14 days after Ad26.COV2.S booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=299 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=295 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=88 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 14 Days After Ad26.COV2.S Booster Vaccination After Completing 2-dose Primary Vaccination With BNT162b2
|
4439 Titer
Interval 4027.0 to 4893.0
|
3566 Titer
Interval 3212.0 to 3958.0
|
3218 Titer
Interval 2582.0 to 4010.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)Population: Pre-dose data prior to primary vaccination with BNT162b2 was not collected and analyzed and thus the planned serological response data post-primary vaccination (BNT162b2) could not be estimated based on the protocol-defined serological response criteria.
Percentage of participants with serological response against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were planned to be reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-dose 1 titer \<LLOQ, then post-vaccination titer \>=4\*LLOQ. (2) If pre-dose 1 titer \>LLOQ, then post-vaccination titer \>=4\*pre-dose 1 value (titer).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against SARS-CoV-2 original strain 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against original strain was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=309 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against SARS-CoV-2 Original Strain 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
|
1281 Titer
Interval 1086.0 to 1510.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (Delta) 14 days after booster vaccination (5\*10\^10 vp dose level) after completing 2-dose primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer). As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response Against SARS-CoV-2 Delta Variant 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
|
93.6 Percentage of participants
Interval 90.2 to 96.1
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 14 days after booster vaccination after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA. As specified in the protocol, data for this outcome measure was not collected and analyzed for Cohort 2: Ad26.COV2.S 2.5\*10\^10 vp and 1\*10\^10 vp participants.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=299 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Leading Variant of High Consequence or Concern (Delta Variant) 14 Days After Booster Vaccination (5*10^10 vp Dose Level) After Completing 2-dose Primary Vaccination With BNT162b2
|
2318 Titer
Interval 2049.0 to 2623.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with seropositive response to vaccination against the SARS-CoV-2 leading variant of high consequence or concern (Delta) 2 weeks to 2 months after completing primary vaccination with 2-dose BNT162b2 were planned to be reported. A participant was considered a responder if one or both of the following conditions was satisfied: (1) Pre-dose titer \<LLOQ and post-vaccination titer \>=4\*LLOQ. or (2) Pre-dose titer \>LLOQ and post-vaccination titer \>=4\*pre-dose 1 titer value.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=309 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Seropositive Response to Vaccination Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing Primary Vaccination With 2-dose BNT162b2 (Pfizer BNT162b2 External Samples)
|
83.8 Percentage of participants
Interval 79.2 to 87.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 2 weeks to 2 months after primary vaccination with BNT162b2 (up to 1.5 months)Population: NI analysis set included all vaccinated participants with post-baseline immunogenicity data without major protocol deviations and who were SARS-COV-2 seronegative at baseline (based on the serological test for SARS CoV-2-specific nucleocapsid antibodies \[N serology\]). Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMTs of neutralizing antibodies against the SARS-CoV-2 leading variant of high consequence or concern (Delta variant) 2 weeks to 2 months after completing 2-dose primary vaccination with BNT162b2 were reported. GMT against delta variant was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=309 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the SARS-CoV-2 Delta Variant 2 Weeks to 2 Months After Completing 2-dose Primary Vaccination With BNT162b2 (Pfizer BNT162b2 External Samples)
|
502 Titer
Interval 422.0 to 598.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 7 days after booster vaccination (Up to Day 8)Population: Full analysis set (FAS) included all participants with a documented study vaccine administration (Ad26.COV2.S).
Participants who received the booster dose were asked to note the occurrence of injection site pain, erythema, and swelling at the study vaccine injection site in e-Diary daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs) After Ad26.COV2.S Booster Vaccination
|
197 Participants
|
149 Participants
|
51 Participants
|
256 Participants
|
243 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Up to 7 days after booster vaccination (Up to Day 8)Population: FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature \>= 38.0 degree Celsius or \>=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs After Ad26.COV2.S Booster Vaccination
|
188 Participants
|
160 Participants
|
60 Participants
|
267 Participants
|
234 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Up to 28 days after booster vaccination (Up to Day 29)Population: FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Unsolicited AEs After Ad26.COV2.S Booster Vaccination
|
37 Participants
|
35 Participants
|
14 Participants
|
55 Participants
|
56 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 1) until 1 year post booster vaccinationPopulation: FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
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 |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Serious Adverse Events (SAEs) After Ad26.COV2.S Booster Vaccination
|
11 Participants
|
7 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 1) until 1 year post booster vaccinationPopulation: FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=330 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohorts 1 and 2: Number of Participants With Adverse Events of Special Interest (AESIs) After Ad26.COV2.S Booster Vaccination
|
2 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: Per protocol immunogenicity (PPI) population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=93 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Original Strain
|
63.4 Percentage of participants
Interval 57.7 to 68.9
|
57.9 Percentage of participants
Interval 52.1 to 63.6
|
64.5 Percentage of participants
Interval 53.9 to 74.2
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Beta Variant
|
40.9 Percentage of participants
Interval 35.3 to 46.8
|
32.0 Percentage of participants
Interval 26.7 to 37.6
|
18.3 Percentage of participants
Interval 11.0 to 27.6
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Delta Variant
|
56.7 Percentage of participants
Interval 50.9 to 62.4
|
49.2 Percentage of participants
Interval 43.3 to 55.0
|
51.6 Percentage of participants
Interval 41.0 to 62.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=270 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=257 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=78 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
|
9.6 Percentage of participants
Interval 6.4 to 13.8
|
8.2 Percentage of participants
Interval 5.1 to 12.2
|
6.4 Percentage of participants
Interval 2.1 to 14.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination were reported. GMT against original strain was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=298 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=93 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
Original Strain
|
1130 Titer
Interval 989.0 to 1291.0
|
915 Titer
Interval 792.0 to 1058.0
|
734 Titer
Interval 564.0 to 954.0
|
—
|
—
|
—
|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
Delta Variant
|
471 Titer
Interval 411.0 to 539.0
|
391 Titer
Interval 335.0 to 456.0
|
316 Titer
Interval 244.0 to 409.0
|
—
|
—
|
—
|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 14 Days After Ad26.COV2.S Booster Vaccination
Beta Variant
|
274 Titer
Interval 240.0 to 314.0
|
237 Titer
Interval 205.0 to 275.0
|
156 Titer
Interval 125.0 to 194.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=270 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=257 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=78 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination
|
69 Titer
Interval to 78.0
Lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
71 Titer
Interval to 81.0
Lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
NA Titer
Interval to 69.0
Geometric mean and lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported. A participant was considered a responder if at least one of the following conditions were satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=32 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=24 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Delta Variant
|
59.4 Percentage of participants
Interval 40.6 to 76.3
|
36.4 Percentage of participants
Interval 20.4 to 54.9
|
62.5 Percentage of participants
Interval 40.6 to 81.2
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Original Strain
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
63.6 Percentage of participants
Interval 45.1 to 79.6
|
75.0 Percentage of participants
Interval 53.3 to 90.2
|
—
|
—
|
—
|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Original Strain, Delta, and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
Beta Variant
|
40.6 Percentage of participants
Interval 23.7 to 59.4
|
18.2 Percentage of participants
Interval 7.0 to 35.5
|
29.2 Percentage of participants
Interval 12.6 to 51.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
Percentage of participants with serological response against SARS-CoV-2 leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with Ad26.COV2.S were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=32 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=29 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Serological Response Against SARS-CoV-2 Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With Ad26.COV2.S
|
9.4 Percentage of participants
Interval 2.0 to 25.0
|
6.9 Percentage of participants
Interval 0.8 to 22.8
|
4.30 Percentage of participants
Interval 0.1 to 21.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination were reported. GMT was assessed by VNA.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=32 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=24 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
Delta Variant
|
455 Titer
Interval 320.0 to 647.0
|
328 Titer
Interval 197.0 to 545.0
|
333 Titer
Interval 183.0 to 608.0
|
—
|
—
|
—
|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
Beta Variant
|
269 Titer
Interval 188.0 to 384.0
|
201 Titer
Interval 127.0 to 321.0
|
190 Titer
Interval 116.0 to 311.0
|
—
|
—
|
—
|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination
Original Strain
|
993 Titer
Interval 688.0 to 1434.0
|
893 Titer
Interval 546.0 to 1459.0
|
887 Titer
Interval 559.0 to 1408.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=32 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=29 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination
|
77 Titer
Interval to 108.0
Lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
NA Titer
Interval to 92.0
Geometric mean and lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
NA Titer
Interval to 85.0
Geometric mean and lower limit of 95% CI could not be estimated as it was below the LLOQ (66).
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population was analyzed. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure and "0" in the number analyzed field signifies that no participants were available for the analysis because data of antibodies binding to SARS-CoV-2 relevant variants of concern was not collected and analyzed due to change in planned analysis.
Percentage of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by ELISA were planned to be reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=32 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=29 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV-2 Proteins by Enzyme-linked Immunosorbent Assay (ELISA)
Individual SARS-CoV-2 Proteins
|
100.0 Percentage of participants
Interval 89.1 to 100.0
|
96.6 Percentage of participants
Interval 82.2 to 99.9
|
100.0 Percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 1) until 1 year from booster vaccinationPopulation: Data for this outcome measure was not collected and analyzed due to change in planned analysis.
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV-2 Proteins by MSD were planned to be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=297 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=294 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=88 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Beta Variant
|
88.2 Percentage of participants
Interval 84.0 to 91.7
|
82.7 Percentage of participants
Interval 77.8 to 86.8
|
78.4 Percentage of participants
Interval 68.4 to 86.5
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Original Strain
|
97.0 Percentage of participants
Interval 94.3 to 98.6
|
90.5 Percentage of participants
Interval 86.5 to 93.6
|
89.8 Percentage of participants
Interval 81.5 to 95.2
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Delta Variant
|
93.6 Percentage of participants
Interval 90.2 to 96.1
|
91.2 Percentage of participants
Interval 87.3 to 94.1
|
86.4 Percentage of participants
Interval 77.4 to 92.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 was reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=299 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=295 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=89 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
|
72.5 Percentage of participants
Interval 67.0 to 77.5
|
62.0 Percentage of participants
Interval 56.2 to 67.6
|
56.2 Percentage of participants
Interval 45.3 to 66.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=299 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=295 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=88 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Original Strain
|
4439 Titer
Interval 4027.0 to 4893.0
|
3566 Titer
Interval 3212.0 to 3958.0
|
3218 Titer
Interval 2582.0 to 4010.0
|
—
|
—
|
—
|
|
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Delta Variant
|
2318 Titer
Interval 2049.0 to 2623.0
|
1872 Titer
Interval 1646.0 to 2129.0
|
1761 Titer
Interval 1372.0 to 2261.0
|
—
|
—
|
—
|
|
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Variant 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Beta Variant
|
1649 Titer
Interval 1432.0 to 1900.0
|
1310 Titer
Interval 1135.0 to 1511.0
|
1055 Titer
Interval 787.0 to 1412.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days after Ad26.COV2.S booster vaccination (i.e., On Day 15)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Antibody GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 14 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=299 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=295 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=89 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Antibody GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 14 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
|
509 Titer
Interval 440.0 to 590.0
|
386 Titer
Interval 327.0 to 455.0
|
336 Titer
Interval 252.0 to 449.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Percentage of participants with serological response to vaccination against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (Beta variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b2 were reported. A participant was considered a responder if at least one of the following conditions was satisfied: (1) If pre-booster 1 titer \<LLOQ, then post-booster titer \>=4\*LLOQ or (2) If pre-booster 1 titer \>LLOQ, then post-booster titer \>=4\*pre-booster value (titer).
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=35 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Original Strain
|
100.0 Percentage of participants
Interval 90.0 to 100.0
|
97.0 Percentage of participants
Interval 84.2 to 99.9
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Delta Variant
|
97.1 Percentage of participants
Interval 85.1 to 99.9
|
97.0 Percentage of participants
Interval 84.2 to 99.9
|
87.0 Percentage of participants
Interval 66.4 to 97.2
|
—
|
—
|
—
|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Original Strain, Delta and Beta Variant 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
Beta Variant
|
94.3 Percentage of participants
Interval 80.8 to 99.3
|
78.8 Percentage of participants
Interval 61.1 to 91.0
|
82.6 Percentage of participants
Interval 61.2 to 95.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
Percentage of participants with serological response to vaccination against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after primary vaccination with BNT162b were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=35 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Serological Response to Vaccination Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Primary Vaccination With BNT162b2
|
77.1 Percentage of participants
Interval 59.9 to 89.6
|
57.6 Percentage of participants
Interval 39.2 to 74.5
|
69.6 Percentage of participants
Interval 47.1 to 86.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
GMTs of neutralizing antibodies against the original strain, leading variant of high consequence or concern (delta variant), and other relevant variant of concern (beta variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=35 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Original Strain
|
6221 Titer
Interval 4905.0 to 7890.0
|
4808 Titer
Interval 3496.0 to 6612.0
|
4410 Titer
Interval 3067.0 to 6341.0
|
—
|
—
|
—
|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Delta Variant
|
3414 Titer
Interval 2358.0 to 4944.0
|
2348 Titer
Interval 1584.0 to 3480.0
|
1803 Titer
Interval 1138.0 to 2855.0
|
—
|
—
|
—
|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the Original Strain, Delta and Beta Strain 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
Beta Variant
|
2144 Titer
Interval 1426.0 to 3226.0
|
1614 Titer
Interval 1031.0 to 2529.0
|
1116 Titer
Interval 579.0 to 2152.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population included all vaccinated participants for whom post-baseline immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure.
GMTs of neutralizing antibodies against the leading variant of high consequence or concern (omicron variant) 28 days after Ad26.COV2.S booster vaccination after completing primary vaccination with BNT162b2 were reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=35 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: GMTs of Neutralizing Antibodies Against the Leading Variant of High Consequence or Concern (Omicron Variant) 28 Days After Ad26.COV2.S Booster Vaccination After Completing Primary Vaccination With BNT162b2
|
752 Titer
Interval 496.0 to 1140.0
|
452 Titer
Interval 282.0 to 724.0
|
391 Titer
Interval 211.0 to 725.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days after Ad26.COV2.S booster vaccination (i.e., On Day 29)Population: PPI population was analyzed. Here, N (Overall number of participants analyzed) signifies participants with available data for this outcome measure and "0" in the number analyzed field signifies that no participants were available for the analysis because data of antibodies binding to SARS-CoV-2 relevant variants of concern was not collected and analyzed due to change in planned analysis.
Percentage of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by ELISA were planned to be reported.
Outcome measures
| Measure |
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=35 Participants
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=33 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=23 Participants
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Antibodies Binding to SARS-CoV-2 Relevant Variants of Concern or Individual SARS-CoV- 2 Proteins by ELISA
Individual SARS-CoV-2 Proteins
|
100.0 Percentage of participants
Interval 90.0 to 100.0
|
100.0 Percentage of participants
Interval 89.4 to 100.0
|
100.0 Percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From booster vaccination (Day 1) until 1 year from booster vaccinationPopulation: Data for this outcome measure was not collected and analyzed due to change in planned analysis.
Number of participants with antibodies binding to SARS-CoV-2 relevant variants of concern or individual SARS-CoV- 2 proteins by MSD were planned to be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1Population: Data for this outcome measure was not collected and analyzed due to change in planned analysis.
Number of participants with antibodies binding to the SARS-CoV-2 nucleocapsid (N) protein at Day 1 as assessed by N-serology were planned to be reported.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Ad26.COV2.S (5*10^10 vp)
Serious events: 11 serious events
Other events: 239 other events
Deaths: 1 deaths
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
Serious events: 7 serious events
Other events: 201 other events
Deaths: 1 deaths
Cohort 1: Ad26.COV2.S (1*10^10 vp)
Serious events: 2 serious events
Other events: 75 other events
Deaths: 0 deaths
Cohort 2: Ad26.COV2.S (5*10^10 vp)
Serious events: 9 serious events
Other events: 294 other events
Deaths: 0 deaths
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
Serious events: 4 serious events
Other events: 271 other events
Deaths: 0 deaths
Cohort 2: Ad26.COV2.S (1*10^10 vp)
Serious events: 2 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Ad26.COV2.S (5*10^10 vp)
n=330 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at 5\*10\^10 virus particle (vp) dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Asthenia
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Chest Pain
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.86%
1/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Fatigue
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.94%
1/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Appendicitis
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Endometritis
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.94%
1/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Musculoskeletal and connective tissue disorders
Posterior Tibial Tendon Dysfunction
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Musculoskeletal and connective tissue disorders
Rib Deformity
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.86%
1/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Headache
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Seizure
|
0.61%
2/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Thoracic Outlet Syndrome
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.30%
1/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Surgical and medical procedures
Spinal Fusion Surgery
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Surgical and medical procedures
Spinal Laminectomy
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Vascular disorders
Giant Cell Arteritis
|
0.30%
1/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
Other adverse events
| Measure |
Cohort 1: Ad26.COV2.S (5*10^10 vp)
n=330 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single intramuscular (IM) injection of Ad26.COV2.S booster vaccination at 5\*10\^10 virus particle (vp) dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (2.5*10^10 vp)
n=326 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 1: Ad26.COV2.S (1*10^10 vp)
n=116 participants at risk
Participants who had received primary vaccination with Ad26.COV2.S (1 dose) in study VAC31518COV3001 (NCT04505722) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (5*10^10 vp)
n=326 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (2.5*10^10 vp)
n=328 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 2.5\*10\^10 vp dose level on Day 1.
|
Cohort 2: Ad26.COV2.S (1*10^10 vp)
n=106 participants at risk
Participants who had received primary vaccination with BNT162b2 (2 doses) were enrolled in this study and received a single IM injection of Ad26.COV2.S booster vaccination at 1\*10\^10 vp dose level on Day 1.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.8%
49/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
12.9%
42/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
9.5%
11/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
31.3%
102/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
22.9%
75/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
11.3%
12/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Fatigue
|
46.7%
154/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
36.5%
119/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
39.7%
46/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
71.8%
234/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
59.1%
194/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
50.0%
53/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Malaise
|
0.91%
3/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.2%
4/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.6%
3/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.31%
1/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.94%
1/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Pyrexia
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.8%
6/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.86%
1/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
9.8%
32/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
5.8%
19/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.94%
1/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Vaccination Site Erythema
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.92%
3/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.86%
1/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.8%
9/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
3.0%
10/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.94%
1/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Vaccination Site Pain
|
59.4%
196/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
45.7%
149/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
43.1%
50/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
78.5%
256/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
73.8%
242/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
57.5%
61/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
General disorders
Vaccination Site Swelling
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.61%
2/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.5%
5/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.4%
8/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.9%
2/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.92%
3/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.86%
1/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.5%
8/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.8%
6/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.8%
3/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
110/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
26.7%
87/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
24.1%
28/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
60.7%
198/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
51.2%
168/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
33.0%
35/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Nervous system disorders
Headache
|
33.3%
110/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
27.9%
91/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
29.3%
34/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
65.6%
214/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
47.0%
154/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
40.6%
43/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.5%
5/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.6%
3/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.61%
2/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.91%
3/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.92%
3/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
3.4%
4/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.2%
4/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.2%
4/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.9%
2/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.2%
4/330 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.5%
5/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
2.6%
3/116 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.61%
2/326 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
1.8%
6/328 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
0.00%
0/106 • From booster vaccination (Day 1) until 1 year post booster vaccination
FAS included all participants with a documented study vaccine administration (Ad26.COV2.S).
|
Additional Information
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. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER