Trial Outcomes & Findings for A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive (NCT NCT05007080)
NCT ID: NCT05007080
Last Updated: 2025-02-04
Results Overview
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
304 participants
Primary outcome timeframe
7 days post-dose 1 on Day 1 (Day 8)
Results posted on
2025-02-04
Participant Flow
Of the 304 randomized participants, 3 participants were randomized to an arm that was closed prior to vaccination due to ethical reasons. One participant was excluded from the analysis due to lack of a valid informed consent form and is not presented in the below table.
Participant milestones
| Measure |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
51
|
49
|
49
|
50
|
|
Overall Study
Vaccinated
|
51
|
50
|
51
|
49
|
49
|
49
|
|
Overall Study
COMPLETED
|
49
|
46
|
50
|
45
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
4
|
2
|
5
|
Reasons for withdrawal
| Measure |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
2
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Randomized not vaccinated
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
Baseline characteristics by cohort
| Measure |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Total
n=299 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 1.87 • n=5 Participants
|
14 years
STANDARD_DEVIATION 1.82 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 1.76 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 1.75 • n=4 Participants
|
14.2 years
STANDARD_DEVIATION 1.8 • n=21 Participants
|
14.1 years
STANDARD_DEVIATION 1.84 • n=8 Participants
|
14.2 years
STANDARD_DEVIATION 1.80 • n=8 Participants
|
|
Age, Customized
Children (2-11 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
Adolescents (12-17 years)
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
299 Participants
n=8 Participants
|
|
Age, Customized
Adults (18-64 years)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
From 65 to 84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
126 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
173 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
124 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
172 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
108 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
88 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
82 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 1 on Day 1 (Day 8)Population: Safety analyses set included all participants with at least one vaccine administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 1
|
12 Participants
|
13 Participants
|
16 Participants
|
17 Participants
|
11 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 2 on Day 57 (Day 64)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs were: injection site pain/tenderness, erythema, swelling at the vaccination site.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=47 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=48 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Local Adverse Events (AEs) at 7 Days Post-dose 2
|
9 Participants
|
8 Participants
|
10 Participants
|
3 Participants
|
16 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 1 on Day 1 (Day 8)Population: Safety analyses set included all participants with at least one vaccine administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 1
|
16 Participants
|
20 Participants
|
13 Participants
|
18 Participants
|
14 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 7 days post-dose 2 on Day 57 (Day 64)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=47 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=48 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Solicited Systemic AEs at 7 Days Post-dose 2
|
10 Participants
|
11 Participants
|
10 Participants
|
4 Participants
|
14 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 28 days post-dose 1 on Day 1 (Day 29)Population: Safety analyses set included all participants with at least one vaccine administration documented.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 1
|
8 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 28 days post-dose 2 on Day 57 (Day 85)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints.
Description: An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=47 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=48 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With Unsolicited AEs at 28 Days Post-dose 2
|
7 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination (Day 1) until 6 months post-dose 1 on Day 1 (Up to Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented.
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, and 5: Number of Participants With Medically-attended Adverse Events (MAAEs) 6 Months Post-Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From the first vaccination (Day 1) until 6 months post-dose 2 on Day 57 (Up to Day 240)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=47 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=48 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Number of Participants With MAAEs 6 Months Post-Dose 2
|
4 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented.
Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, and 3: Number of Participants With MAAEs Leading to Discontinuation
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)Population: Safety analyses set included all participants with at least one vaccine administration documented.
Number of participants with MAAEs leading to discontinuation were reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 4, 5 and 6: Number of Participants With MAAEs Leading to Discontinuation
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented.
SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
|
—
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)Population: Safety analyses set included all participants with at least one vaccine administration documented.
SAE were defined as any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 4, 5 and 6: Number of Participants With Serious Adverse Events (SAEs)
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented. 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with AESI (including MIS-C) were reported. Thrombotic events (suspected deep vessel venous or arterial thrombotic events); Thrombocytopenia (platelet count below 150,000/μL) and MIS-C (a subject \<21 years with fever, evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement \[cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological\]; \& No alternative diagnoses; \& Positive for ositive for current or recent (SARS-CoV-2) coronavirus disease 2019 \[COVID-19\] infection by Real-time reverse transcriptase-polymerase chain reaction \[RT-PCR\], serology, or antigen test; Or COVID-19 exposure within the 4 weeks prior to the onset of symptoms) were considered AESIs in this study.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=13 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=18 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=15 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI) (Including Multisystem Inflammatory Syndrome in Children [MIS-C])
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first vaccination on Day 1 up to Day 240 (6 months after second vaccination on Day 57)Population: Safety analyses set included all participants with at least one vaccine administration documented. 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Number of participants with AESI (including MIS-C) were reported. Thrombotic events: suspected deep vessel venous or arterial thrombotic events and Thrombocytopenia, defined as platelet count below 150,000/μL and MIS-C were considered as AESIs in this study. MIS-C, defined as: An individual aged \<21 years presenting with fever, laboratory evidence of inflammation, and evidence of clinically severe illness requiring hospitalization, with multisystem (≥2) organ involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic,or neurological); AND No alternative plausible diagnoses; AND Positive for current or recent SARS-CoV-2 (COVID-19) infection by RT-PCR, serology, or antigen test; or COVID-19 exposure within the 4 weeks prior to the onset of symptoms.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=46 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=47 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=47 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 4, 5 and 6: Number of Participants With AESI (Including MIS-C)
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 28 days post-dose 1 on Day 1 (Day 29)Population: The Per Protocol Immunogenicity (PPI) set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Serological response to vaccination measured by S-ELISA (ELISA Unit/milliliter (EU/mL)) at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of less than or equal to the lower limit of quantification (\<=LLOQ) and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=39 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=44 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=42 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=43 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=35 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=41 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Spike-enzyme-linked Immunosorbent Assay (S-ELISA) at 28 Days Post-dose 1
|
6758 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 4344 • Interval 4344.0 to 10513.0
|
6533 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 4341 • Interval 4341.0 to 9831.0
|
7812 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 5120 • Interval 5120.0 to 11920.0
|
5881 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 3719 • Interval 3719.0 to 9302.0
|
9273 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 5596 • Interval 5596.0 to 15366.0
|
6069 ELISA Unit/milliliter (EU/mL)
95% Confidence Interval 3780 • Interval 3780.0 to 9745.0
|
PRIMARY outcome
Timeframe: 14 days post-dose 2 on Day 57 (Day 71)Population: The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Serological response to vaccination measured by S-ELISA (EU/mL) at 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=32 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=38 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=31 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=38 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=30 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=37 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by S-ELISA at 14 Days Post-dose 2
|
8716 EU/mL
95% Confidence Interval 6577 • Interval 6577.0 to 11550.0
|
4923 EU/mL
95% Confidence Interval 3329 • Interval 3329.0 to 7282.0
|
4679 EU/mL
95% Confidence Interval 2748 • Interval 2748.0 to 7967.0
|
4043 EU/mL
95% Confidence Interval 2480 • Interval 2480.0 to 6590.0
|
8958 EU/mL
95% Confidence Interval 6333 • Interval 6333.0 to 12671.0
|
6522 EU/mL
95% Confidence Interval 4461 • Interval 4461.0 to 9533.0
|
PRIMARY outcome
Timeframe: 28 days post-dose 1 on Day 1 (Day 29)Population: The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" number of participants analyzed signifies the number of participants that were evaluable for this outcome measure.
Serological response to vaccination measured by VNA titers at 28 days post-dose 1 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=39 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=43 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=42 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=42 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=35 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=41 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Virus Neutralization Assay (VNA) Titers 28 Days Post-dose 1
|
1878 Titers
Interval 1089.0 to 3240.0
|
1325 Titers
Interval 792.0 to 2216.0
|
1754 Titers
Interval 988.0 to 3113.0
|
1392 Titers
Interval 806.0 to 2403.0
|
2038 Titers
Interval 1065.0 to 3897.0
|
1455 Titers
Interval 864.0 to 2449.0
|
PRIMARY outcome
Timeframe: 14 days post-dose 2 on Day 57 (Day 71)Population: The PPI set included all randomized and vaccinated participants for whom immunogenicity data were available excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here "N" number of participants analyzed signifies the number of participants that were evaluable for this outcome measure.
Serological response to vaccination measured by VNA titers 14 days post-dose 2 were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=32 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=38 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=31 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=38 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=30 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=37 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Serological Response to Vaccination Measured by VNA Titers 14 Days Post-dose 2
|
2670 Titers
Interval 1816.0 to 3925.0
|
1187 Titers
Interval 698.0 to 2018.0
|
1094 Titers
Interval 517.0 to 2315.0
|
864 Titers
Interval 471.0 to 1583.0
|
2386 Titers
Interval 1453.0 to 3917.0
|
1742 Titers
Interval 1064.0 to 2852.0
|
SECONDARY outcome
Timeframe: Groups 1-3: Days 1, 29, 57, 71, 184, 198, and 366; Groups 4-6: Days 1, 29, 57, 71 and 240Population: PPI set: all randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure, and "n"(number analyzed) signifies participants analyzed at specified timepoints (where "n=0", data were not planned to be analyzed at specified timepoint for specific arm).
Serological response to vaccination measured by binding antibody titers to SARS-CoV-2 or individual SARS-CoV-2 S proteins as assessed by ELISA were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 1
|
200 EU/mL
Interval 117.0 to 341.0
|
255 EU/mL
Interval 148.0 to 438.0
|
297 EU/mL
Interval 156.0 to 563.0
|
338 EU/mL
Interval 189.0 to 605.0
|
256 EU/mL
Interval 144.0 to 455.0
|
282 EU/mL
Interval 151.0 to 528.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 29
|
6758 EU/mL
Interval 4344.0 to 10513.0
|
6533 EU/mL
Interval 4341.0 to 9831.0
|
7812 EU/mL
Interval 5120.0 to 11920.0
|
5881 EU/mL
Interval 3719.0 to 9302.0
|
9273 EU/mL
Interval 5596.0 to 15366.0
|
6069 EU/mL
Interval 3780.0 to 9745.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 57
|
5650 EU/mL
Interval 3798.0 to 8405.0
|
5629 EU/mL
Interval 3896.0 to 8133.0
|
7450 EU/mL
Interval 4934.0 to 11249.0
|
4554 EU/mL
Interval 2922.0 to 7099.0
|
7034 EU/mL
Interval 4542.0 to 10891.0
|
4817 EU/mL
Interval 3009.0 to 7710.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 71
|
8716 EU/mL
Interval 6577.0 to 11550.0
|
4923 EU/mL
Interval 3329.0 to 7282.0
|
4679 EU/mL
Interval 2748.0 to 7967.0
|
4043 EU/mL
Interval 2480.0 to 6590.0
|
8958 EU/mL
Interval 6333.0 to 12671.0
|
6522 EU/mL
Interval 4461.0 to 9533.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 184
|
—
|
4131 EU/mL
Interval 2431.0 to 7021.0
|
4765 EU/mL
Interval 2048.0 to 11087.0
|
3861 EU/mL
Interval 1826.0 to 8165.0
|
—
|
—
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 198
|
—
|
6782 EU/mL
Interval 5230.0 to 8795.0
|
7656 EU/mL
Interval 5317.0 to 11026.0
|
10506 EU/mL
Interval 8227.0 to 13417.0
|
—
|
—
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 240
|
5338 EU/mL
Interval 3039.0 to 9377.0
|
—
|
—
|
—
|
4994 EU/mL
Interval 3144.0 to 7932.0
|
3877 EU/mL
Interval 2390.0 to 6289.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Binding Antibody Titers to Severe Acute Respiratory Syndrome Coronavirus(-2) (SARS-CoV-2) or Individual SARS-CoV-2 S Proteins as Assessed by ELISA
Day 366
|
—
|
5087 EU/mL
Interval 3809.0 to 6793.0
|
4934 EU/mL
Interval 2856.0 to 8526.0
|
6585 EU/mL
Interval 4907.0 to 8838.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Groups 1-3: Days 1, 29, 57, 71, 184, 198 and 366; Groups 4-6: Days 1, 29, 57, 71 and 240Population: PPI set: all randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure, and "n"(number analyzed) signifies participants analyzed at specified timepoints (where "n=0", data were not planned to be analyzed at specified timepoint for specific arm). "NA"=\<LLOQ.
Serological response to vaccination measured by neutralizing antibody titers to SARS-CoV-2 (VNA) were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=48 Participants
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=50 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=48 Participants
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 1
|
83 Titers
Interval to 121.0
"NA" signifies that the value is \<LLOQ.
|
105 Titers
Interval to 163.0
"NA" signifies that the value is \<LLOQ.
|
149 Titers
Interval 88.0 to 250.0
|
114 Titers
Interval to 186.0
"NA" signifies that the value is \<LLOQ.
|
112 Titers
Interval to 184.0
"NA" signifies that the value is \<LLOQ.
|
127 Titers
Interval 77.0 to 210.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 29
|
1878 Titers
Interval 1089.0 to 3240.0
|
1325 Titers
Interval 792.0 to 2216.0
|
1754 Titers
Interval 988.0 to 3113.0
|
1392 Titers
Interval 806.0 to 2403.0
|
2038 Titers
Interval 1065.0 to 3897.0
|
1455 Titers
Interval 864.0 to 2449.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 57
|
1434 Titers
Interval 847.0 to 2427.0
|
1197 Titers
Interval 710.0 to 2020.0
|
1743 Titers
Interval 992.0 to 3065.0
|
993 Titers
Interval 570.0 to 1730.0
|
1662 Titers
Interval 923.0 to 2992.0
|
1188 Titers
Interval 649.0 to 2173.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 71
|
2670 Titers
Interval 1816.0 to 3925.0
|
1187 Titers
Interval 698.0 to 2018.0
|
1094 Titers
Interval 517.0 to 2315.0
|
864 Titers
Interval 471.0 to 1583.0
|
2386 Titers
Interval 1453.0 to 3917.0
|
1742 Titers
Interval 1064.0 to 2852.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 184
|
—
|
1358 Titers
Interval 773.0 to 2386.0
|
1702 Titers
Interval 462.0 to 6273.0
|
860 Titers
Interval 326.0 to 2267.0
|
—
|
—
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 198
|
—
|
2496 Titers
Interval 1760.0 to 3539.0
|
2547 Titers
Interval 1223.0 to 5303.0
|
4083 Titers
Interval 3006.0 to 5547.0
|
—
|
—
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 240
|
1900 Titers
Interval 1035.0 to 3489.0
|
—
|
—
|
—
|
1867 Titers
Interval 944.0 to 3692.0
|
1134 Titers
Interval 548.0 to 2347.0
|
|
Groups 1, 2, 3, 4, 5 and 6: Serological Response to Vaccination Measured by Neutralizing Antibody Titers to SARS-CoV-2
Day 366
|
—
|
1809 Titers
Interval 1231.0 to 2656.0
|
1783 Titers
Interval 691.0 to 4599.0
|
2274 Titers
Interval 1521.0 to 3401.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were pre-defined as local (at the injection site) AEs for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=48 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Number of Participants With Solicited Local AEs for 7 Days Post-booster Vaccination
|
—
|
19 Participants
|
16 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 up to Day 191 (7 days after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs were used to assess the reactogenicity of the study vaccine and were predefined as systemic AES for which participants were specifically asked and which were noted by participants in their reactogenicity diary for 7 days post each vaccination. Participants were instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (day of vaccination and the subsequent 7 days) for the following solicited systemic AEs: fatigue, headache, nausea, myalgia and pyrexia. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=48 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Number of Participants With Solicited Systemic AEs for 7 Days Post-booster Vaccination
|
—
|
16 Participants
|
14 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 up to Day 212 (28 days after booster Vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited AEs that started within 7 days after vaccination but were ongoing after this 7-day window after each vaccination are also considered unsolicited AEs. Unsolicited AEs were defined as AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=48 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Number of Participants With Unsolicited AEs for 28 Days Post-booster Vaccination
|
—
|
6 Participants
|
8 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first vaccination on Day 1 up to Day 366 (6 months after booster vaccination on Day 184)Population: Safety analyses set included all participants with at least one vaccine administration documented. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure.
MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not be considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in the study protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=48 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=49 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Number of Participants With MAAEs Until 6 Months Post-booster Vaccination
|
—
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 184, 198 and 366Population: PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints.
Serological response to post-booster vaccination measured by binding (S-ELISA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=27 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=21 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=31 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers
Day 184
|
—
|
4131 EU/mL
Interval 2431.0 to 7021.0
|
4765 EU/mL
Interval 2048.0 to 11087.0
|
3861 EU/mL
Interval 1826.0 to 8165.0
|
—
|
—
|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers
Day 198
|
—
|
6782 EU/mL
Interval 5230.0 to 8795.0
|
7656 EU/mL
Interval 5317.0 to 11026.0
|
10506 EU/mL
Interval 8227.0 to 13417.0
|
—
|
—
|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Binding (S-ELISA) Antibody Titers
Day 366
|
—
|
5087 EU/mL
Interval 3809.0 to 6793.0
|
4934 EU/mL
Interval 2856.0 to 8526.0
|
6585 EU/mL
Interval 4907.0 to 8838.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 184, 198 and 366Population: PPI set: All randomized and vaccinated participants with available immunogenicity data excluding data from participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n" (number analyzed) signifies number of participants analyzed at specified timepoints.
Serological response to post-booster vaccination measured by neutralizing (VNA) antibody titers were reported. For Vaccine-specific responses, a participant was defined as a responder if: 1. a baseline sample value of \<=LLOQ and a postbaseline sample strictly greater than the LLOQ; or 2. a baseline sample value strictly \>LLOQ and a postbaseline sample value representing an at least 4-fold increase from the baseline sample value, was reported. Data were expressed as IC50 units. Data for this outcome measure was not planned to be collected and analyzed for groups 4, 5 and 6 as pre-specified in protocol.
Outcome measures
| Measure |
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Participants received single doses of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=27 Participants
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=21 Participants
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=31 Participants
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers
Day 184
|
—
|
1358 Titers
Interval 773.0 to 2386.0
|
1702 Titers
Interval 462.0 to 6273.0
|
860 Titers
Interval 326.0 to 2267.0
|
—
|
—
|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers
Day 198
|
—
|
2496 Titers
Interval 1760.0 to 3539.0
|
2547 Titers
Interval 1223.0 to 5303.0
|
4083 Titers
Interval 3006.0 to 5547.0
|
—
|
—
|
|
Groups 1, 2 and 3: Serological Response to Post-booster Vaccination Measured by Neutralizing (VNA) Antibody Titers
Day 366
|
—
|
1809 Titers
Interval 1231.0 to 2656.0
|
1783 Titers
Interval 691.0 to 4599.0
|
2274 Titers
Interval 1521.0 to 3401.0
|
—
|
—
|
Adverse Events
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
Serious events: 1 serious events
Other events: 32 other events
Deaths: 1 deaths
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 participants at risk
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 participants at risk
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 participants at risk
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur Fracture
|
2.0%
1/51 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/50 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/50 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Surgical and medical procedures
Vaginal Cyst Excision
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/50 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/49 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
Other adverse events
| Measure |
Group 1: Ad26.COV2.S 2.5*10^10 vp + Placebo
n=51 participants at risk
Participants received a single dose of Ad26.COV.S 2.5\*10\^10 virus particle (vp) as intramuscular (IM) injection on Day 1 and placebo matching to Ad26.COV.S 2.5\*10\^10 vp as IM injection on Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 2: Ad26.COV2.S 1.25*10^10 vp + Placebo
n=50 participants at risk
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 1.25\*10\^10 vp as IM injectionon Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 3: Ad26.COV2.S 0.625*10^10 vp + Placebo
n=51 participants at risk
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and placebo matching to Ad26.COV2.S 0.625\*10\^10 vp as IM injection Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination. Participants received booster vaccination with Ad26.COV.S 2.5\*10\^10 vp on Day 184.
|
Group 4: Ad26.COV2.S 2.5*10^10 vp + Ad26.COV2.S 2.5*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 2.5\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
Group 5: Ad26.COV2.S 1.25*10^10 vp + Ad26.COV2.S 1.25*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 1.25\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination
|
Group 6: Ad26.COV2.S 0.625*10^10 vp + Ad26.COV2.S 0.625*10^10 vp
n=49 participants at risk
Participants received a single dose of Ad26.COV2.S 0.625\*10\^10 vp as IM injection on Day 1 and Day 57. Participants were unblinded to the primary vaccination regimen at 6 months after the first vaccination.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
3/51 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.0%
2/50 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/51 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Gastrointestinal disorders
Nausea(Solicited)
|
15.7%
8/51 • Number of events 8 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.0%
5/50 • Number of events 6 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
21.6%
11/51 • Number of events 13 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
12.2%
6/49 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
14.3%
7/49 • Number of events 8 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
General disorders
Fatigue(Solicited)
|
39.2%
20/51 • Number of events 26 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
22.0%
11/50 • Number of events 17 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
23.5%
12/51 • Number of events 14 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
32.7%
16/49 • Number of events 21 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
20.4%
10/49 • Number of events 11 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
28.6%
14/49 • Number of events 16 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
General disorders
Pyrexia(Solicited)
|
19.6%
10/51 • Number of events 12 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.0%
2/50 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
13.7%
7/51 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
14.3%
7/49 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.2%
5/49 • Number of events 5 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
General disorders
Vaccination Site Erythema(Solicited)
|
7.8%
4/51 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.0%
5/50 • Number of events 8 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
3.9%
2/51 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.1%
3/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.2%
4/49 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.1%
3/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
General disorders
Vaccination Site Pain(Solicited)
|
45.1%
23/51 • Number of events 38 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
44.0%
22/50 • Number of events 39 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
47.1%
24/51 • Number of events 34 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
38.8%
19/49 • Number of events 26 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
30.6%
15/49 • Number of events 18 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
38.8%
19/49 • Number of events 22 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
General disorders
Vaccination Site Swelling(Solicited)
|
9.8%
5/51 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
14.0%
7/50 • Number of events 8 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
5.9%
3/51 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.2%
4/49 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.2%
4/49 • Number of events 5 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Infections and infestations
Covid-19
|
13.7%
7/51 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.0%
4/50 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
7.8%
4/51 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.2%
4/49 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
14.3%
7/49 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
12.2%
6/49 • Number of events 6 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Infections and infestations
Gastroenteritis
|
3.9%
2/51 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.0%
3/50 • Number of events 4 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/51 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/49 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.1%
3/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Infections and infestations
Influenza
|
9.8%
5/51 • Number of events 6 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.0%
3/50 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
11.8%
6/51 • Number of events 10 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
4.1%
2/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.2%
5/49 • Number of events 5 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Infections and infestations
Rhinitis
|
5.9%
3/51 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/50 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/51 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/49 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/49 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.9%
2/51 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.0%
5/50 • Number of events 7 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
3.9%
2/51 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
8.2%
4/49 • Number of events 6 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Musculoskeletal and connective tissue disorders
Myalgia(Solicited)
|
35.3%
18/51 • Number of events 21 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
22.0%
11/50 • Number of events 15 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
27.5%
14/51 • Number of events 18 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
26.5%
13/49 • Number of events 16 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
18.4%
9/49 • Number of events 11 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
10.2%
5/49 • Number of events 6 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Nervous system disorders
Headache(Solicited)
|
31.4%
16/51 • Number of events 28 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
40.0%
20/50 • Number of events 26 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
33.3%
17/51 • Number of events 20 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
24.5%
12/49 • Number of events 17 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
34.7%
17/49 • Number of events 21 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
32.7%
16/49 • Number of events 18 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.9%
2/51 • Number of events 2 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/50 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/51 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
2.0%
1/49 • Number of events 1 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
6.1%
3/49 • Number of events 3 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
0.00%
0/49 • Groups 1, 2, 3: From first vaccination on Day 1 untill 6 months after booster vaccination on Day 184 (end of study) (up to Day 366) Groups 4, 5, 6: From first vaccination on Day 1 until 6 months after second vaccination on Day 57 (end of study) (up to Day 240)
Safety analyses included all subjects with at least one vaccine administration documented.
|
Additional Information
Clinical Franchise Leader
Janssen Vaccines & Prevention B.V.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
- Publication restrictions are in place
Restriction type: OTHER