Trial Outcomes & Findings for A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults (NCT NCT04908722)
NCT ID: NCT04908722
Last Updated: 2025-02-04
Results Overview
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1609 participants
Primary outcome timeframe
28 days after first vaccination (at Day 29)
Results posted on
2025-02-04
Participant Flow
A total of 1609 participants were enrolled, but 1 participant was randomized by error. This participant was never treated and was removed from the randomized list.
As planned, the Participant flow, baseline characteristics, Outcome measures data and adverse events data were analyzed and reported combined for the main study and sub-study.
Participant milestones
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
291
|
222
|
293
|
222
|
291
|
289
|
|
Overall Study
Main Study
|
222
|
222
|
223
|
222
|
222
|
221
|
|
Overall Study
Sub Study
|
69
|
0
|
70
|
0
|
69
|
68
|
|
Overall Study
Treated
|
288
|
221
|
291
|
220
|
288
|
285
|
|
Overall Study
Per Protocol Immunogenicity Set
|
276
|
212
|
282
|
212
|
277
|
271
|
|
Overall Study
COMPLETED
|
237
|
178
|
244
|
179
|
240
|
233
|
|
Overall Study
NOT COMPLETED
|
54
|
44
|
49
|
43
|
51
|
56
|
Reasons for withdrawal
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol deviation
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
33
|
33
|
36
|
30
|
32
|
34
|
|
Overall Study
Physician Decision
|
1
|
1
|
1
|
2
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
12
|
8
|
7
|
6
|
12
|
14
|
|
Overall Study
Other
|
3
|
1
|
3
|
2
|
4
|
1
|
|
Overall Study
Initiated prohibited medication
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Randomized but not vaccinated
|
3
|
1
|
2
|
2
|
3
|
4
|
Baseline Characteristics
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
Total
n=1593 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 10.21 • n=5 Participants
|
35.2 years
STANDARD_DEVIATION 9.87 • n=7 Participants
|
34.8 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 9.36 • n=4 Participants
|
34.5 years
STANDARD_DEVIATION 9.81 • n=21 Participants
|
33.4 years
STANDARD_DEVIATION 9.63 • n=8 Participants
|
34.7 years
STANDARD_DEVIATION 9.81 • n=8 Participants
|
|
Age, Customized
Adults (18-64 years)
|
288 Participants
n=5 Participants
|
221 Participants
n=7 Participants
|
291 Participants
n=5 Participants
|
220 Participants
n=4 Participants
|
288 Participants
n=21 Participants
|
285 Participants
n=8 Participants
|
1593 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/Gender, Customized
Female
|
117 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
590 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Male
|
170 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
148 Participants
n=4 Participants
|
182 Participants
n=21 Participants
|
182 Participants
n=8 Participants
|
1002 Participants
n=8 Participants
|
|
Sex/Gender, Customized
Undifferentiated
|
1 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
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
132 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
130 Participants
n=8 Participants
|
682 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
130 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
135 Participants
n=8 Participants
|
779 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
132 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
104 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
101 Participants
n=8 Participants
|
502 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
161 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
183 Participants
n=21 Participants
|
163 Participants
n=8 Participants
|
961 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
86 Participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
155 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
142 Participants
n=8 Participants
|
811 Participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
368 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
22 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
122 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
54 Participants
n=8 Participants
|
292 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 28 days after first vaccination (at Day 29)Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analysed) signifies participants who were evaluable for this outcome measure.
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=249 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=191 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=250 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=189 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=243 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=251 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After First Vaccination
|
2351 ELISA Units per millilitre (EU/mL)
Interval 1849.0 to 2989.0
|
1714 ELISA Units per millilitre (EU/mL)
Interval 1305.0 to 2250.0
|
2189 ELISA Units per millilitre (EU/mL)
Interval 1726.0 to 2775.0
|
1377 ELISA Units per millilitre (EU/mL)
Interval 1062.0 to 1786.0
|
1626 ELISA Units per millilitre (EU/mL)
Interval 1255.0 to 2106.0
|
1976 ELISA Units per millilitre (EU/mL)
Interval 1521.0 to 2566.0
|
PRIMARY outcome
Timeframe: 14 days after second vaccination (at Day 71)Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Geometric mean concentration of SARS-CoV-2 S protein binding antibodies measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=171 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=130 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=180 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=134 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=172 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=184 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) S Protein Binding Antibodies Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 14 Days After Second Vaccination
|
4997 ELISA Units per millilitre (EU/mL)
Interval 4145.0 to 6023.0
|
3757 ELISA Units per millilitre (EU/mL)
Interval 3030.0 to 4659.0
|
3855 ELISA Units per millilitre (EU/mL)
Interval 3185.0 to 4666.0
|
3460 ELISA Units per millilitre (EU/mL)
Interval 2781.0 to 4304.0
|
3641 ELISA Units per millilitre (EU/mL)
Interval 2969.0 to 4465.0
|
3905 ELISA Units per millilitre (EU/mL)
Interval 3113.0 to 4897.0
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Day 71, Week 32, and Week 60Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Percentage of participants with serological response to vaccination to SARS-COV-2 S protein as measured by ELISA were reported. A participant was considered a responder if one or both of the following conditions were satisfied: (1) the baseline (pre-dose 1) sample value was less than or equal to (\<=) lower limit of quantification (LLOQ) and the post-baseline sample was greater than (\>) LLOQ; (2) the baseline sample (pre-dose 1) value was \>LLOQ and the post-baseline sample value represented an at least 4-fold (\>=4-fold) increase from the baseline sample value. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=249 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=191 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=250 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=189 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=243 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=251 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Day 29
|
82.7 Percentage of participants
|
90.1 Percentage of participants
|
78.8 Percentage of participants
|
87.8 Percentage of participants
|
80.2 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Day 57
|
81.9 Percentage of participants
|
88.6 Percentage of participants
|
80.2 Percentage of participants
|
92.0 Percentage of participants
|
81.3 Percentage of participants
|
77.7 Percentage of participants
|
|
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Day 71
|
81.9 Percentage of participants
|
92.3 Percentage of participants
|
79.4 Percentage of participants
|
91.8 Percentage of participants
|
80.8 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Week 32
|
72.3 Percentage of participants
|
83.7 Percentage of participants
|
68.0 Percentage of participants
|
86.7 Percentage of participants
|
68.6 Percentage of participants
|
63.2 Percentage of participants
|
|
Percentage of Participants With Serological Response to Vaccination to SARS-COV-2 S Protein as Measured by ELISA
Week 60
|
68.9 Percentage of participants
|
81.8 Percentage of participants
|
61.9 Percentage of participants
|
83.8 Percentage of participants
|
60.0 Percentage of participants
|
53.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 29, Day 57, Day 71, Week 32, and Week 60Population: The per protocol immunogenicity set included all randomized and vaccinated participants for whom immunogenicity data were available excluding participants with major protocol deviations expected to impact the immunogenicity outcomes. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Geometric mean concentration of SARS-CoV-2 S protein binding antibody measured by ELISA were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=249 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=191 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=250 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=189 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=243 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=251 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Day 29
|
2351 ELISA Unit (EU)/mL
Interval 1849.0 to 2989.0
|
1714 ELISA Unit (EU)/mL
Interval 1305.0 to 2250.0
|
2189 ELISA Unit (EU)/mL
Interval 1726.0 to 2775.0
|
1377 ELISA Unit (EU)/mL
Interval 1062.0 to 1786.0
|
1626 ELISA Unit (EU)/mL
Interval 1255.0 to 2106.0
|
1976 ELISA Unit (EU)/mL
Interval 1521.0 to 2566.0
|
|
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Week 60
|
4968 ELISA Unit (EU)/mL
Interval 3119.0 to 7915.0
|
5010 ELISA Unit (EU)/mL
Interval 3146.0 to 7981.0
|
2363 ELISA Unit (EU)/mL
Interval 1448.0 to 3857.0
|
2191 ELISA Unit (EU)/mL
Interval 1224.0 to 3921.0
|
2769 ELISA Unit (EU)/mL
Interval 1776.0 to 4317.0
|
3664 ELISA Unit (EU)/mL
Interval 2169.0 to 6190.0
|
|
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Day 57
|
2722 ELISA Unit (EU)/mL
Interval 2156.0 to 3438.0
|
1842 ELISA Unit (EU)/mL
Interval 1404.0 to 2417.0
|
2089 ELISA Unit (EU)/mL
Interval 1651.0 to 2643.0
|
1622 ELISA Unit (EU)/mL
Interval 1233.0 to 2134.0
|
1919 ELISA Unit (EU)/mL
Interval 1481.0 to 2486.0
|
2293 ELISA Unit (EU)/mL
Interval 1766.0 to 2978.0
|
|
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Day 71
|
4997 ELISA Unit (EU)/mL
Interval 4145.0 to 6023.0
|
3757 ELISA Unit (EU)/mL
Interval 3030.0 to 4659.0
|
3855 ELISA Unit (EU)/mL
Interval 3185.0 to 4666.0
|
3460 ELISA Unit (EU)/mL
Interval 2781.0 to 4304.0
|
3641 ELISA Unit (EU)/mL
Interval 2969.0 to 4465.0
|
3905 ELISA Unit (EU)/mL
Interval 3113.0 to 4897.0
|
|
Geometric Mean Concentration of SARS-CoV-2 S Protein Binding Antibody Measured by ELISA
Week 32
|
3331 ELISA Unit (EU)/mL
Interval 2499.0 to 4438.0
|
2903 ELISA Unit (EU)/mL
Interval 2076.0 to 4058.0
|
2616 ELISA Unit (EU)/mL
Interval 2001.0 to 3420.0
|
2059 ELISA Unit (EU)/mL
Interval 1470.0 to 2885.0
|
3067 ELISA Unit (EU)/mL
Interval 2268.0 to 4148.0
|
2707 ELISA Unit (EU)/mL
Interval 2000.0 to 3662.0
|
SECONDARY outcome
Timeframe: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participant in their e-diary for 7 days after each vaccination. Solicited local AEs included injection site pain/tenderness, erythema and swelling at the study vaccine injection site. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
After first vaccination
|
179 Participants
|
143 Participants
|
162 Participants
|
137 Participants
|
155 Participants
|
133 Participants
|
|
Number of Subjects With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination
After second vaccination
|
130 Participants
|
100 Participants
|
124 Participants
|
95 Participants
|
111 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: 7 days after each vaccination (first vaccination [at Day 8], second vaccination [at Day 64])Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of subjects analysed) signifies number of subjects evaluable for this timepoint.
An AE was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs (include body temperature, fatigue, headache, nausea, myalgia) were noted in the subject diary after 7 days of each vaccination. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
After first vaccination
|
204 Participants
|
156 Participants
|
173 Participants
|
135 Participants
|
156 Participants
|
152 Participants
|
|
Number of Subjects With Solicited Systemic AEs for 7 Days After Each Vaccination
After second vaccination
|
144 Participants
|
98 Participants
|
111 Participants
|
91 Participants
|
105 Participants
|
109 Participants
|
SECONDARY outcome
Timeframe: 28 days after each vaccination (first vaccination [at Day 29], second vaccination [at Day 85])Population: Full analysis set included all participants with at least one vaccine administration documented. Here, 'n' (number of participants analyzed) signifies number of participants evaluable for this timepoint.
Unsolicited AEs were all AEs for which the subject was not specifically questioned in the subject diary. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
After first vaccination
|
78 Participants
|
60 Participants
|
55 Participants
|
58 Participants
|
69 Participants
|
59 Participants
|
|
Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination
After second vaccination
|
55 Participants
|
28 Participants
|
49 Participants
|
39 Participants
|
53 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)Population: Full analysis set included all participants with at least one vaccine administration documented.
SAE was any untoward medical occurrence that at any dose may results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
13 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)Population: Full analysis set included all participants with at least one vaccine administration documented.
AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome were considered to be an AESI. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 60 weeksPopulation: Full analysis set included all participants with at least one vaccine administration documented.
Number of participants with AEs leading to study discontinuation were reported. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Participants With AEs Leading to Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after second vaccination (up to 32 weeks)Population: Full analysis 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 considered medically-attended visits. New onset of chronic diseases were collected as part of the MAAEs. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
Outcome measures
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 Participants
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 Participants
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 Participants
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 Participants
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Medically-Attended Adverse Events (MAAEs)
|
54 Participants
|
34 Participants
|
50 Participants
|
35 Participants
|
48 Participants
|
35 Participants
|
Adverse Events
Group 1: Ad26.COV2.S 9x10^10 vp
Serious events: 13 serious events
Other events: 245 other events
Deaths: 1 deaths
Group 2: Ad26.COV2.S 7x10^10 vp
Serious events: 3 serious events
Other events: 187 other events
Deaths: 0 deaths
Group 3: Ad26.COV2.S 5x10^10 vp
Serious events: 4 serious events
Other events: 236 other events
Deaths: 0 deaths
Group 4: Ad26.COV2.S 3.5x10^10 vp
Serious events: 4 serious events
Other events: 188 other events
Deaths: 0 deaths
Group 5: Ad26.COV2.S 2.5x10^10 vp
Serious events: 3 serious events
Other events: 228 other events
Deaths: 0 deaths
Group 6: Ad26.COV2.S 1.25x10^10 vp
Serious events: 5 serious events
Other events: 217 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 participants at risk
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 participants at risk
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 participants at risk
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Psychiatric disorders
Suicide Attempt
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Cardiac disorders
Myopericarditis
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Death
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Drowning
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Appendicitis
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Cellulitis
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Pelvic Abscess
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/221 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Carotid Artery Dissection
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Myasthenia Gravis
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational Diabetes
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Psychiatric disorders
Anxiety
|
0.35%
1/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/221 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Reproductive system and breast disorders
Ovarian Cyst Torsion
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Reproductive system and breast disorders
Ovarian Disorder
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/221 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/291 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
Other adverse events
| Measure |
Group 1: Ad26.COV2.S 9x10^10 vp
n=288 participants at risk
Participants in the main study and sub study received Intramuscular (IM) injection of Ad26.COV2.S 9x10\^10 viral particles (vp) on Days 1 and 57.
|
Group 2: Ad26.COV2.S 7x10^10 vp
n=221 participants at risk
Participants in the main study received IM injection of Ad26.COV2.S 7x10\^10 vp on Days 1 and 57.
|
Group 3: Ad26.COV2.S 5x10^10 vp
n=291 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 5x10\^10 vp on Days 1 and 57.
|
Group 4: Ad26.COV2.S 3.5x10^10 vp
n=220 participants at risk
Participants in the main study received IM injection of Ad26.COV2.S 3.5x10\^10 vp on Days 1 and 57.
|
Group 5: Ad26.COV2.S 2.5x10^10 vp
n=288 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 2.5x10\^10 vp on Days 1 and 57.
|
Group 6: Ad26.COV2.S 1.25x10^10 vp
n=285 participants at risk
Participants in the main study and sub study received IM injection of Ad26.COV2.S 1.25x10\^10 vp on Days 1 and 57.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.7%
5/288 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/221 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.7%
8/291 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/220 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.1%
6/288 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
8/288 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.2%
7/220 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
4/288 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.2%
9/285 • Number of events 15 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
6/288 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
3/221 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.0%
3/291 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
3/220 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.70%
2/285 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/288 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/291 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/220 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.7%
5/288 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
5/285 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Nausea(Solicited)
|
33.0%
95/288 • Number of events 123 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
35.3%
78/221 • Number of events 99 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
23.0%
67/291 • Number of events 79 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
26.4%
58/220 • Number of events 71 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
22.2%
64/288 • Number of events 78 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
22.8%
65/285 • Number of events 80 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Odynophagia
|
1.0%
3/288 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.0%
3/291 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/288 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
5/285 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
4/288 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/221 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.1%
6/291 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/288 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.70%
2/285 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Chills
|
3.8%
11/288 • Number of events 13 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/291 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/220 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
4/288 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Fatigue
|
5.2%
15/288 • Number of events 19 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
5.0%
11/221 • Number of events 14 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.4%
7/291 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
4.1%
9/220 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.7%
5/288 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
5.3%
15/285 • Number of events 22 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Fatigue(Solicited)
|
59.4%
171/288 • Number of events 248 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
63.3%
140/221 • Number of events 202 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
49.5%
144/291 • Number of events 207 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
51.4%
113/220 • Number of events 164 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
43.1%
124/288 • Number of events 173 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
46.3%
132/285 • Number of events 178 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Pyrexia
|
3.1%
9/288 • Number of events 14 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
4.5%
10/221 • Number of events 14 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.7%
5/291 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
4/220 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
4/288 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.5%
7/285 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Pyrexia(Solicited)
|
23.6%
68/288 • Number of events 77 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
18.6%
41/221 • Number of events 42 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
11.3%
33/291 • Number of events 37 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
12.3%
27/220 • Number of events 27 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
7.6%
22/288 • Number of events 25 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
5.6%
16/285 • Number of events 17 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Vaccination Site Erythema(Solicited)
|
1.0%
3/288 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.1%
9/291 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
4/220 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
5/285 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Vaccination Site Pain
|
2.4%
7/288 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.6%
8/221 • Number of events 12 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
4/291 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
3/220 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.1%
6/288 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.8%
8/285 • Number of events 10 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Vaccination Site Pain(Solicited)
|
68.8%
198/288 • Number of events 306 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
70.6%
156/221 • Number of events 242 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
65.3%
190/291 • Number of events 284 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
69.5%
153/220 • Number of events 231 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
60.8%
175/288 • Number of events 265 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
56.1%
160/285 • Number of events 234 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
General disorders
Vaccination Site Swelling(Solicited)
|
2.8%
8/288 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
4.1%
9/221 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.1%
9/291 • Number of events 12 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
3/220 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.0%
3/288 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.8%
8/285 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Covid-19
|
3.1%
9/288 • Number of events 14 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
9.5%
21/221 • Number of events 30 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
6.9%
20/291 • Number of events 28 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
9.1%
20/220 • Number of events 29 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
7.6%
22/288 • Number of events 35 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
4.6%
13/285 • Number of events 19 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Influenza
|
12.2%
35/288 • Number of events 57 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
11.8%
26/221 • Number of events 31 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
13.1%
38/291 • Number of events 50 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
11.8%
26/220 • Number of events 41 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
12.8%
37/288 • Number of events 52 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
8.8%
25/285 • Number of events 35 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
3/288 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.2%
7/221 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.4%
7/291 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.7%
6/220 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.8%
8/288 • Number of events 13 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
4.2%
12/285 • Number of events 13 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Infections and infestations
Rhinitis
|
2.8%
8/288 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.7%
6/221 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.34%
1/291 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
4/220 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.5%
10/288 • Number of events 11 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.70%
2/285 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.5%
10/288 • Number of events 12 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
5.4%
12/221 • Number of events 17 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.1%
6/291 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
5.5%
12/220 • Number of events 15 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.4%
7/288 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
6.3%
18/285 • Number of events 20 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia(Solicited)
|
63.5%
183/288 • Number of events 260 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
57.0%
126/221 • Number of events 175 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
49.5%
144/291 • Number of events 188 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
52.3%
115/220 • Number of events 159 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
41.0%
118/288 • Number of events 159 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
38.9%
111/285 • Number of events 151 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Headache
|
9.0%
26/288 • Number of events 28 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
6.3%
14/221 • Number of events 20 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.8%
11/291 • Number of events 12 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
9.5%
21/220 • Number of events 25 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
8.0%
23/288 • Number of events 26 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
7.7%
22/285 • Number of events 28 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Nervous system disorders
Headache(Solicited)
|
63.9%
184/288 • Number of events 260 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
62.9%
139/221 • Number of events 202 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
50.2%
146/291 • Number of events 195 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
49.5%
109/220 • Number of events 150 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
46.2%
133/288 • Number of events 175 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
43.2%
123/285 • Number of events 165 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
7/288 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.3%
5/221 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.0%
3/291 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
3.2%
7/220 • Number of events 7 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
2.4%
7/288 • Number of events 8 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.4%
4/285 • Number of events 5 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
6/288 • Number of events 6 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/291 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.45%
1/220 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.69%
2/288 • Number of events 2 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.35%
1/285 • Number of events 1 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
|
Vascular disorders
Hypertension
|
2.1%
6/288 • Number of events 9 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/221 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.0%
3/291 • Number of events 3 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
1.8%
4/220 • Number of events 4 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/288 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
0.00%
0/285 • From Day 1 (post-vaccination) up to end of the study (up to 60 weeks)
Full analysis set included all participants with at least one vaccine administration documented. As per planned analysis, the data were analyzed and reported combined for the main study and sub-study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER