Trial Outcomes & Findings for Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older (NCT NCT04537208)
NCT ID: NCT04537208
Last Updated: 2025-09-17
Results Overview
Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 36). LLOQ of the neutralization assay was a titer of 10.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
441 participants
Primary outcome timeframe
Day 36 (post-vaccination)
Results posted on
2025-09-17
Participant Flow
The study was conducted at 10 active sites in the United States between 03 September 2020 to 19 November 2021.
A total of 441 participants were enrolled, of which 439 were vaccinated in the study.
Participant milestones
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
Participants received a single intramuscular (IM) injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
34
|
34
|
34
|
28
|
84
|
27
|
85
|
18
|
29
|
|
Overall Study
Vaccinated on Day 1
|
34
|
34
|
34
|
34
|
34
|
28
|
82
|
27
|
85
|
18
|
29
|
|
Overall Study
Vaccinated on Day 22
|
0
|
0
|
0
|
0
|
0
|
26
|
80
|
26
|
85
|
17
|
29
|
|
Overall Study
Safety Analysis Set (SafAS)
|
36
|
36
|
35
|
34
|
34
|
26
|
80
|
26
|
85
|
18
|
29
|
|
Overall Study
COMPLETED
|
26
|
31
|
28
|
27
|
26
|
23
|
71
|
24
|
69
|
14
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
6
|
7
|
8
|
5
|
13
|
3
|
16
|
4
|
8
|
Reasons for withdrawal
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
Participants received a single intramuscular (IM) injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine low-dose (LD) formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
Participants received a single IM injection of SARS-CoV2 vaccine high-dose (HD) formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol deviation
|
0
|
0
|
2
|
0
|
0
|
2
|
4
|
0
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
1
|
3
|
5
|
1
|
6
|
1
|
7
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
3
|
4
|
3
|
2
|
3
|
2
|
7
|
2
|
2
|
Baseline Characteristics
Study of Recombinant Protein Vaccine Formulations Against COVID-19 in Healthy Adults 18 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=27 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
Total
n=441 Participants
Total of all reporting groups
|
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=28 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=84 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 15.5 • n=40 Participants
|
44.7 years
STANDARD_DEVIATION 15.5 • n=8 Participants
|
34.8 years
STANDARD_DEVIATION 10.2 • n=62 Participants
|
43.2 years
STANDARD_DEVIATION 16.2 • n=95 Participants
|
42.1 years
STANDARD_DEVIATION 15.0 • n=129 Participants
|
42.8 years
STANDARD_DEVIATION 14.2 • n=93 Participants
|
41.9 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 15.5 • n=27 Participants
|
39.0 years
STANDARD_DEVIATION 17.2 • n=483 Participants
|
39.6 years
STANDARD_DEVIATION 15.7 • n=36 Participants
|
43.7 years
STANDARD_DEVIATION 14.1 • n=10 Participants
|
42.9 years
STANDARD_DEVIATION 14.9 • n=115 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=40 Participants
|
44 Participants
n=8 Participants
|
10 Participants
n=62 Participants
|
14 Participants
n=95 Participants
|
229 Participants
n=129 Participants
|
22 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
18 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=40 Participants
|
41 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
15 Participants
n=95 Participants
|
212 Participants
n=129 Participants
|
12 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
14 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
3 Participants
n=129 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=95 Participants
|
28 Participants
n=129 Participants
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=129 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=95 Participants
|
15 Participants
n=129 Participants
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=40 Participants
|
78 Participants
n=8 Participants
|
16 Participants
n=62 Participants
|
26 Participants
n=95 Participants
|
383 Participants
n=129 Participants
|
29 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
30 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
5 Participants
n=129 Participants
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=95 Participants
|
6 Participants
n=129 Participants
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination)Population: Analysis was performed on Per-protocol analysis set for immunogenicity (PPAS-IAS) population which included all participants who received at least one injection of study intervention and had evaluable immunogenicity data, with no major protocol violations. Here, "overall number of participants analyzed" signifies participants with available data for this outcome measure (OM).
GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 1
|
5.00 titers
95% confidence interval (CI) was not computable as the standard deviation (SD) of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
PRIMARY outcome
Timeframe: Day 22 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=69 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 22
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.27 titers
Interval 4.72 to 5.89
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.29 titers
Interval 4.89 to 5.73
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.59 titers
Interval 4.93 to 6.34
|
5.35 titers
Interval 4.62 to 6.19
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
PRIMARY outcome
Timeframe: Day 36 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=22 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=19 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=24 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=60 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=66 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=11 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=19 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 36
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.31 titers
Interval 4.69 to 6.01
|
5.17 titers
Interval 4.83 to 5.53
|
11.5 titers
Interval 6.17 to 21.4
|
17.4 titers
Interval 12.1 to 25.0
|
31.2 titers
Interval 16.4 to 59.4
|
69.0 titers
Interval 48.3 to 98.5
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
5.00 titers
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold-rise (GMFR) of Serum Neutralization Antibody Titers at Day 22
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.05 ratio
Interval 0.945 to 1.18
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.06 ratio
Interval 0.977 to 1.15
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.12 ratio
Interval 0.986 to 1.27
|
1.07 ratio
Interval 0.924 to 1.24
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 36 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=22 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=19 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=24 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=16 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=59 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=65 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=11 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=19 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold-rise of Serum Neutralization Antibody Titers at Day 36
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.06 ratio
Interval 0.938 to 1.2
|
1.03 ratio
Interval 0.966 to 1.11
|
2.42 ratio
Interval 1.26 to 4.67
|
3.36 ratio
Interval 2.33 to 4.85
|
6.24 ratio
Interval 3.27 to 11.9
|
14.0 ratio
Interval 9.78 to 20.1
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1.00 ratio
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 22 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 22) and pre-vaccination (on Day 1) i.e., Day 22/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22
>=4-fold rise
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >=2-fold and >=4-fold Rise in Serum Neutralization Antibody Titers at Day 22
>=2-fold rise
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 (pre-vaccination) and Day 36 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of neutralizing antibodies post-vaccination (on Day 36) and pre-vaccination (on Day 1) i.e., Day 36/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=22 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=19 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=24 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=16 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=59 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=65 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=11 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=19 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36
>=2-fold rise
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
31 Participants
|
14 Participants
|
57 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >=2-Fold and >=4-Fold Rise in Serum Neutralization Antibody Titer at Day 36
>=4-fold rise
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
22 Participants
|
14 Participants
|
49 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 22 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Seroconversion was defined as participants with a Baseline (Day 1) titer value below lower limit of quantification (LLOQ) with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 22). LLOQ of the neutralization assay was a titer of 10.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 22
|
0 percentage of participants
Interval 0.0 to 14.2
|
0 percentage of participants
Interval 0.0 to 16.8
|
0 percentage of participants
Interval 0.0 to 16.8
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
0 percentage of participants
Interval 0.0 to 13.7
|
0 percentage of participants
Interval 0.0 to 19.5
|
3.0 percentage of participants
Interval 0.4 to 10.4
|
0 percentage of participants
Interval 0.0 to 15.4
|
5.9 percentage of participants
Interval 1.6 to 14.4
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
0 percentage of participants
Interval 0.0 to 15.4
|
PRIMARY outcome
Timeframe: Day 36 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM.
Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (at Day 36). LLOQ of the neutralization assay was a titer of 10.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=22 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=19 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=24 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=16 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=59 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=65 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=11 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=19 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV-2 Virus Antigens at Day 36
|
0 percentage of participants
Interval 0.0 to 15.4
|
0 percentage of participants
Interval 0.0 to 16.1
|
0 percentage of participants
Interval 0.0 to 17.6
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
4.2 percentage of participants
Interval 0.1 to 21.1
|
43.8 percentage of participants
Interval 19.8 to 70.1
|
52.5 percentage of participants
Interval 39.1 to 65.7
|
70.0 percentage of participants
Interval 45.7 to 88.1
|
87.7 percentage of participants
Interval 77.2 to 94.5
|
0 percentage of participants
Interval 0.0 to 28.5
|
0 percentage of participants
Interval 0.0 to 17.6
|
PRIMARY outcome
Timeframe: Within 30 minutes post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])Population: Analyzed on safety analysis set (SafAS) population which included randomized participants who had received at least one injection of study intervention and were analyzed according to study intervention they actually received. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions prelisted in the case report form (CRF) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post vaccination 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post any vaccination
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Immediate Unsolicited Adverse Events (AEs)
Post vaccination 2
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post any and each vaccination (Vaccination 1 [i.e., at Day 1] and 2 [i.e., at Day 22])Population: Analysis was performed on SafAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.
A solicited reaction (SR) was defined as an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited injection site reactions included pain, erythema and swelling. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=33 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=79 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Injection Site Reactions
Pain post-any vaccination
|
18 Participants
|
30 Participants
|
21 Participants
|
28 Participants
|
5 Participants
|
19 Participants
|
73 Participants
|
20 Participants
|
80 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain post-vaccination 1
|
18 Participants
|
30 Participants
|
21 Participants
|
28 Participants
|
5 Participants
|
16 Participants
|
53 Participants
|
13 Participants
|
64 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Pain post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
19 Participants
|
70 Participants
|
19 Participants
|
78 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema post-any vaccination
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
19 Participants
|
4 Participants
|
39 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema post-vaccination 1
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Erythema post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
19 Participants
|
4 Participants
|
37 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling post-any vaccination
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
16 Participants
|
4 Participants
|
27 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling post-vaccination 1
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Injection Site Reactions
Swelling post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
3 Participants
|
15 Participants
|
4 Participants
|
26 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Within 7 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])Population: Analysis was performed on SafAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.
An SR was defined as an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the protocol and CRF and considered as related to vaccination. Solicited systemic reactions included fever, headache, malaise and myalgia. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=33 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Systemic Reactions
Fever post-any vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
28 Participants
|
5 Participants
|
25 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Fever post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
28 Participants
|
5 Participants
|
23 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache post-any vaccination
|
10 Participants
|
13 Participants
|
4 Participants
|
11 Participants
|
6 Participants
|
14 Participants
|
60 Participants
|
17 Participants
|
59 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache post-vaccination 1
|
10 Participants
|
13 Participants
|
4 Participants
|
11 Participants
|
6 Participants
|
3 Participants
|
20 Participants
|
7 Participants
|
34 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Headache post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
13 Participants
|
57 Participants
|
16 Participants
|
53 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise post-any vaccination
|
6 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
15 Participants
|
61 Participants
|
19 Participants
|
68 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise post-vaccination 1
|
6 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
4 Participants
|
16 Participants
|
6 Participants
|
24 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Malaise post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
13 Participants
|
59 Participants
|
18 Participants
|
64 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia post-any vaccination
|
6 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
6 Participants
|
15 Participants
|
63 Participants
|
19 Participants
|
69 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia post-vaccination 1
|
6 Participants
|
12 Participants
|
13 Participants
|
15 Participants
|
6 Participants
|
5 Participants
|
22 Participants
|
9 Participants
|
32 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Solicited Systemic Reactions
Myalgia post-vaccination 2
|
—
|
—
|
—
|
—
|
—
|
12 Participants
|
60 Participants
|
18 Participants
|
65 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Within 21 days post any and each vaccination (Vaccination 1 [i.e., Day 1] and 2 [i.e., Day 22])Population: Analysis was performed on SafAS population. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were available for assessment for the specified Group, as there was only 1 vaccination administered to Cohort 1.
An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessary had to have a causal relationship with treatment. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset post-vaccination. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited Adverse Events
Post vaccination 1
|
10 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
3 Participants
|
13 Participants
|
8 Participants
|
26 Participants
|
3 Participants
|
7 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post vaccination 2
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
29 Participants
|
5 Participants
|
39 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Unsolicited Adverse Events
Post any vaccination
|
10 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
13 Participants
|
34 Participants
|
11 Participants
|
50 Participants
|
5 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)Population: Analysis was performed on SafAS population.
A MAAE were AEs with a new onset or a worsening of a condition that prompted the participant to seek unplanned medical advice at a physician's office (including phone contact or email) or emergency department. An AE was defined as any untoward medical occurrence in a participant who received study vaccine and does not necessarily had to have a causal relationship with treatment. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Medically Attended Adverse Events (MAAE)
|
5 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
11 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)Population: Analysis was performed on SafAS population.
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)Population: Analysis was performed on SafAS population.
An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in the study protocol.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 8 days post last dose (i.e., up to Day 9 for Cohort 1 and up to Day 30 for Cohort 2)Population: Analysis was performed on SafAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM and 'number analyzed' = participants with available data for each specified category. Reported data for each arm were presented as pre-specified in the study protocol.
Laboratory tests included hemoglobin (male and female), above and below normal white blood cell, lymphocytes, neutrophils \& eosinophils, platelet count, creatinine and blood urea nitrogen, hyponatremia \& hypernatremia, hyperkalemia \& hypokalemia, hyperglycemia (non-fasting), hypoproteinemia, alkaline phosphate, alanine aminotransferase, aspartate aminotransferase, bilirubin (with any increase in liver function test \[LFT\], bilirubin (normal in LFT), amylase \& lipase, Urine: protein, glucose \& blood. The US FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adults and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" was used for grading. As per the guidance, Grade 1 = mild, Grade 2 = moderate and Grade 3 = severe.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=32 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=34 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=33 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=33 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=78 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=28 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypoproteinemia: Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alanine aminotransferase: Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Lipase: Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Aspartate aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Aspartate aminotransferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with any increase in LFT: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with any increase in LFT: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with any increase in LFT: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with normal in LFT: Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with normal in LFT: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Bilirubin - with normal in LFT: Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Amylase: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Amylase: Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Amylase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Lipase: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Lipase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - protein: Grade 1
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
4 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - protein: Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - protein: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - glucose: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - glucose: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - glucose: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - blood: Grade 1
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - blood: Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Urine - blood: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Creatinine: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Platelets Decreased: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Creatinine: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin: Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypoproteinemia: Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypoproteinemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Blood Urea Nitrogen: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Creatinine: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Blood Urea Nitrogen: Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Female): Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Female): Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Female): Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Male): Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Male): Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Blood Urea Nitrogen: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyponatremia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Below normal white blood cell: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyponatremia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyponatremia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypernatremia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypernatremia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypernatremia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperkalemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperkalemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hemoglobin (Male): Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperkalemia: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypokalemia: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypokalemia: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hypokalemia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperglycemia: Grade 1
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperglycemia: Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Hyperglycemia: Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Above normal white blood cell: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Above normal white blood cell: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Above normal white blood cell: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Below normal white blood cell: Grade 1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Below normal white blood cell: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Lymphocytes Decreased: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Lymphocytes Decreased: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Lymphocytes Decreased: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Neutrophils Decreased: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Neutrophils Decreased: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Neutrophils Decreased: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Eosinophils: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Eosinophils: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Absolute Eosinophils: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Platelets Decreased: Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Platelets Decreased: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alkaline phosphate: Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alkaline phosphate: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alkaline phosphate: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alanine aminotransferase: Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Alanine aminotransferase: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Test Results Based on US FDA Toxicity Grading Guidance
Aspartate aminotransferase: Grade 1
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)Population: Analysis was performed on PPAS-IAS population. Here, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
GMC of Anti-S binding antibodies were assessed using enzyme-linked immunosorbent assay (ELISA) and were measured in binding antibody units/milliliter (BAU/mL).
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=69 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 1
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
9.80 BAU/mL
Interval 9.08 to 10.6
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
10.1 BAU/mL
Interval 8.76 to 11.8
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
11.7 BAU/mL
Interval 8.56 to 15.9
|
9.66 BAU/mL
Interval 9.25 to 10.1
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
9.73 BAU/mL
Interval 9.18 to 10.3
|
10.5 BAU/mL
Interval 8.34 to 13.3
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 22
|
34.7 BAU/mL
Interval 18.8 to 63.8
|
61.8 BAU/mL
Interval 35.8 to 107.0
|
46.1 BAU/mL
Interval 24.8 to 86.0
|
160 BAU/mL
Interval 78.4 to 327.0
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
45.2 BAU/mL
Interval 21.0 to 97.0
|
88.4 BAU/mL
Interval 60.6 to 129.0
|
50.2 BAU/mL
Interval 28.6 to 88.4
|
136 BAU/mL
Interval 101.0 to 184.0
|
10.4 BAU/mL
Interval 8.44 to 12.8
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 36
|
26.0 BAU/mL
Interval 13.9 to 48.8
|
73.7 BAU/mL
Interval 43.2 to 126.0
|
41.0 BAU/mL
Interval 22.2 to 75.5
|
136 BAU/mL
Interval 70.2 to 264.0
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
1049 BAU/mL
Interval 448.0 to 2457.0
|
3571 BAU/mL
Interval 2597.0 to 4910.0
|
3086 BAU/mL
Interval 1781.0 to 5346.0
|
7842 BAU/mL
Interval 6120.0 to 10049.0
|
29.8 BAU/mL
Interval 15.4 to 57.4
|
9.45 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 181
|
50.9 BAU/mL
Interval 15.0 to 172.0
|
145 BAU/mL
Interval 27.8 to 757.0
|
21.7 BAU/mL
Interval 11.2 to 42.2
|
127 BAU/mL
Interval 21.1 to 765.0
|
44.6 BAU/mL
Interval 9.75 to 204.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
925 BAU/mL
Interval 2.78 to 307000.0
|
828 BAU/mL
Interval 344.0 to 1993.0
|
1338 BAU/mL
Interval 154.0 to 11655.0
|
3451 BAU/mL
Interval 1439.0 to 8275.0
|
28070 BAU/mL
Interval 7802.0 to 101000.0
|
217 BAU/mL
Interval 4.01 to 11732.0
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 366
|
2161 BAU/mL
Interval 92.8 to 50304.0
|
7355 BAU/mL
Interval 221.0 to 245000.0
|
1250 BAU/mL
Interval 126.0 to 12379.0
|
12580 BAU/mL
Interval 2121.0 to 74606.0
|
6265 BAU/mL
Interval 361.0 to 109000.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Concentration (GMC) of Anti-S Binding Antibody at Day 1, 22, 36, 181, 202, 366 and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
3439 BAU/mL
Interval 0.0 to 1000000.0
|
9009 BAU/mL
Interval 738.0 to 110000.0
|
24115 BAU/mL
Interval 10016.0 to 58060.0
|
37532 BAU/mL
Interval 13416.0 to 105000.0
|
4114 BAU/mL
Interval 0.641 to 26400000.0
|
1126 BAU/mL
95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
Binding antibody titers were evaluated by ELISA. Fold-rise was calculated as the ratio of geometric mean concentrations of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 01, Day 36/Day 01, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=17 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 22/Day 1
|
3.67 ratio
Interval 1.99 to 6.76
|
6.30 ratio
Interval 3.69 to 10.8
|
4.88 ratio
Interval 2.62 to 9.1
|
15.8 ratio
Interval 8.08 to 30.8
|
1.00 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
3.67 ratio
Interval 1.85 to 7.28
|
9.12 ratio
Interval 6.24 to 13.3
|
5.32 ratio
Interval 3.02 to 9.36
|
13.8 ratio
Interval 10.2 to 18.7
|
0.989 ratio
Interval 0.966 to 1.01
|
1.00 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 36/Day 1
|
2.75 ratio
Interval 1.47 to 5.16
|
7.52 ratio
Interval 4.45 to 12.7
|
4.34 ratio
Interval 2.35 to 7.99
|
13.4 ratio
Interval 7.18 to 25.1
|
1.00 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
91.0 ratio
Interval 36.6 to 226.0
|
367 ratio
Interval 267.0 to 504.0
|
327 ratio
Interval 188.0 to 566.0
|
812 ratio
Interval 621.0 to 1061.0
|
2.78 ratio
Interval 1.34 to 5.75
|
1.00 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 181/Day 1
|
5.39 ratio
Interval 1.59 to 18.2
|
14.5 ratio
Interval 2.76 to 76.3
|
2.30 ratio
Interval 1.18 to 4.47
|
13.4 ratio
Interval 2.23 to 80.9
|
4.72 ratio
Interval 1.03 to 21.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 202/Day 1
|
—
|
—
|
—
|
—
|
—
|
58.2 ratio
Interval 0.91 to 3722.0
|
68.9 ratio
Interval 30.3 to 156.0
|
142 ratio
Interval 16.2 to 1233.0
|
387 ratio
Interval 157.0 to 954.0
|
2970 ratio
Interval 826.0 to 10687.0
|
23.0 ratio
Interval 0.424 to 1241.0
|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 366/Day 1
|
229 ratio
Interval 9.82 to 5323.0
|
685 ratio
Interval 21.0 to 22298.0
|
132 ratio
Interval 13.4 to 1310.0
|
1331 ratio
Interval 224.0 to 7895.0
|
663 ratio
Interval 38.2 to 11509.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold-rise (GMFR) of Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 387/Day 1
|
—
|
—
|
—
|
—
|
—
|
364 ratio
Interval 0.0 to 1000000.0
|
933 ratio
Interval 53.9 to 16147.0
|
2552 ratio
Interval 1060.0 to 6144.0
|
3972 ratio
Interval 1420.0 to 11111.0
|
435 ratio
Interval 0.068 to 2800000.0
|
119 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination); Day 22 (post-vaccination), Day 36 (post-vaccination), Day 181 (only for Cohort 1), Day 202 (only for Cohort 2), Day 366 (only for Cohort 1), and Day 387 (only for Cohort 2)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
Binding Antibody Titers were evaluated by ELISA. Fold rise (2-fold and 4-fold) was calculated as the ratio of titer values for binding antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Day 22/Day 1 and Day 36/Day 1, Day 181/Day 1, Day 202/Day 1, Day 366/Day 1, and Day 387/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=21 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=20 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=24 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=25 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=18 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=67 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=22 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=68 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=13 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=22 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 22/Day 1: >=2-fold rise
|
14 Participants
|
17 Participants
|
15 Participants
|
21 Participants
|
0 Participants
|
10 Participants
|
55 Participants
|
17 Participants
|
66 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 22/Day 1: >=4-fold rise
|
10 Participants
|
12 Participants
|
9 Participants
|
18 Participants
|
0 Participants
|
8 Participants
|
46 Participants
|
13 Participants
|
56 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 36/Day 1: >=2-fold rise
|
9 Participants
|
18 Participants
|
14 Participants
|
21 Participants
|
0 Participants
|
15 Participants
|
59 Participants
|
20 Participants
|
65 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 36/Day 1: >=4-fold rise
|
8 Participants
|
15 Participants
|
9 Participants
|
20 Participants
|
0 Participants
|
15 Participants
|
58 Participants
|
20 Participants
|
65 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 181/Day 1: >=4-fold rise
|
6 Participants
|
10 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 202/Day 1: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
25 Participants
|
8 Participants
|
26 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 202/Day 1: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
4 Participants
|
25 Participants
|
8 Participants
|
26 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 366/Day 1: >=2-fold rise
|
5 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 366/Day 1: >=4-fold rise
|
5 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 387/Day 1: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
9 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 387/Day 1: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With >=2-Fold and >=4- Fold Rise in Anti-S Binding Antibody Concentration at Day 22, 36, 181, 202, 366 and 387
Day 181/Day 1: >=2-fold rise
|
10 Participants
|
11 Participants
|
6 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
GMTs of SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=14 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=11 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=16 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=8 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=27 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=5 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387
Day 181
|
6.89 titers
Interval 3.91 to 12.2
|
8.81 titers
Interval 3.74 to 20.7
|
5.00 titers
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
9.99 titers
Interval 3.62 to 27.5
|
10.9 titers
Interval 4.73 to 25.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
31.7 titers
Interval 0.089 to 11282.0
|
14.5 titers
Interval 6.47 to 32.4
|
30.8 titers
Interval 3.5 to 271.0
|
53.6 titers
Interval 21.3 to 135.0
|
355 titers
Interval 84.7 to 1486.0
|
16.0 titers
Interval 2.18 to 117.0
|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387
Day 366
|
35.6 titers
Interval 6.67 to 190.0
|
159 titers
Interval 21.2 to 1199.0
|
36.3 titers
Interval 3.51 to 376.0
|
127 titers
Interval 29.3 to 551.0
|
242 titers
Interval 33.4 to 1761.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers of Neutralizing Antibodies Against SARS-CoV-2 Recombinant Protein Vaccine Formulations at Day 181, 202, 366 and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
30.1 titers
Interval 0.0 to 240000000000.0
|
235 titers
Interval 28.8 to 1913.0
|
727 titers
Interval 361.0 to 1465.0
|
1043 titers
Interval 324.0 to 3355.0
|
39.7 titers
Interval 0.006 to 245000.0
|
23.0 titers
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. Fold-rise was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., for Cohort 1: Day 181/Day 1 and Day 366/Day 1; Cohort 2: Day 202/Day 1 and Day 387/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=14 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=11 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=16 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=25 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=8 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=5 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 181/Day 1
|
1.38 ratio
Interval 0.781 to 2.43
|
1.76 ratio
Interval 0.748 to 4.15
|
1.00 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
2.00 ratio
Interval 0.724 to 5.51
|
2.19 ratio
Interval 0.947 to 5.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 202/Day 1
|
—
|
—
|
—
|
—
|
—
|
6.34 ratio
Interval 0.018 to 2256.0
|
2.38 ratio
Interval 1.15 to 4.91
|
6.16 ratio
Interval 0.699 to 54.3
|
11.7 ratio
Interval 4.59 to 30.1
|
71.0 ratio
Interval 16.9 to 297.0
|
3.20 ratio
Interval 0.436 to 23.5
|
|
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 366/Day 1
|
7.12 ratio
Interval 1.33 to 38.0
|
31.9 ratio
Interval 4.23 to 240.0
|
7.26 ratio
Interval 0.701 to 75.2
|
25.4 ratio
Interval 5.86 to 110.0
|
48.5 ratio
Interval 6.67 to 352.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Fold-rise of Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 387/Day 1
|
—
|
—
|
—
|
—
|
—
|
6.02 ratio
Interval 0.0 to 1000000.0
|
49.5 ratio
Interval 4.55 to 539.0
|
145 ratio
Interval 72.2 to 293.0
|
209 ratio
Interval 64.8 to 671.0
|
7.95 ratio
Interval 0.001 to 49046.0
|
4.60 ratio
NA Explanation: 95% CI was not computable as the SD of the sample was 0, since all participants had the same value.
|
SECONDARY outcome
Timeframe: Day 1 (pre-vaccination), Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
SARS-CoV-2 neutralizing antibodies was measured using a neutralization assay. The fold rise (2-fold and 4-fold) was calculated as the ratio of titer values of antibodies post-vaccination at specified timepoints and pre-vaccination (on Day 1) i.e., Cohort 1: Day 181/Day 1 and Day 366/Day 1 and Cohort 2: Day 202/Day 1 and Day 387/Day 1.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=14 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=11 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=16 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=25 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=8 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=5 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 202/Day 1: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
5 Participants
|
3 Participants
|
14 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 366/Day 1: >=2-fold rise
|
4 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 181/Day 1: >=2-fold rise
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 202/Day 1: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
6 Participants
|
3 Participants
|
19 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 181/Day 1: >=4-fold rise
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 387/Day 1: >=2-fold rise
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 366/Day 1: >=4-fold rise
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With 2-Fold and 4-Fold Rise in Serum Neutralization Antibody Titer at Day 181, 202, 366 and 387
Day 387/Day 1: >=4-fold rise
|
—
|
—
|
—
|
—
|
—
|
1 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387 (post-vaccination)Population: Analysis was performed on PPAS-IAS population. Here, "overall number of participants analyzed" signifies participants with available data for this OM, 'number analyzed' = participants with available data for each specified category and '0' in the number analyzed field denotes that none of the participants were evaluable for assessment in the specified Group for the specified time point.
Seroconversion was defined as participants with a Baseline (Day 1) titer value below LLOQ with a detectable neutralization antibody titer above assay LLOQ post vaccination (Cohort 1: Day 181 and Day 366 and Cohort 2: Day 202 and Day 387). LLOQ of the neutralization assay was a titer of 10.
Outcome measures
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=14 Participants
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=11 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=15 Participants
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=16 Participants
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=25 Participants
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=8 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=26 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=4 Participants
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=5 Participants
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387
Day 181
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
14.3 percentage of participants
Interval 1.8 to 42.8
|
0 percentage of participants
Interval 0.0 to 28.5
|
13.3 percentage of participants
Interval 1.7 to 40.5
|
25.0 percentage of participants
Interval 7.3 to 52.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387
Day 202
|
—
|
—
|
—
|
—
|
—
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
24.0 percentage of participants
Interval 9.4 to 45.1
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
73.1 percentage of participants
Interval 52.2 to 88.4
|
100 percentage of participants
Interval 39.8 to 100.0
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387
Day 366
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Achieving Seroconversion Against SARS-CoV2 Virus Antigens at Day 181, 202, 366 and 387
Day 387
|
—
|
—
|
—
|
—
|
—
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
77.8 percentage of participants
Interval 40.0 to 97.2
|
100 percentage of participants
Interval 54.1 to 100.0
|
100 percentage of participants
Interval 69.2 to 100.0
|
100 percentage of participants
Interval 15.8 to 100.0
|
100 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)Population: Data for this OM (virologically confirmed COVID-19 like illness) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.
Virologically-confirmed COVID-19-like illness was defined by specified clinical symptoms and signs and confirmed by positive result for SARS-CoV-2 by nucleic acid amplification test (NAAT) on a respiratory sample in association with a COVID-19-like illness. The various COVID-19-like illness symptoms were cough, fever, anosmia, ageusia, chillblains, difficulty breathing, shortness of breath, pneumonia, stroke, myocarditis, myocardial infarction, thromboembolic event, purpura fulminans, pharyngitis, chills, myalgia, headache, rhinorrhea, abdominal pain, nausea, diarrhea and vomiting.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cohort 1: up to Day 366 (post-vaccination) and Cohort 2: up to Day 387 (post-vaccination)Population: Data for this OM (serologically confirmed SARS-CoV2 infection) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.
Serologically-confirmed SARS-CoV-2 infection was defined as a change from negative to positive result in serum for presence of antibodies specific to non-Spike protein of SARS-CoV-2 detected by ELISA assay from any post-baseline sampling time point compared to the Baseline value.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 1 up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2Population: Data for this OM (Correlates of Risk / Protection Based on Antibody Responses to SARS-CoV-2) was not collected and analyzed because of the limited number of COVID-19 cases before receiving an authorized/approved COVID-19 vaccine, and thus the corresponding anti-nucleoprotein testing was not conducted, and the planned efficacy analysis was not performed.
Correlate of risk / protection based on antibody responses to SARS-CoV-2 was evaluated using virus neutralization or ELISA, considering virologically-confirmed COVID-19-like illness and/or serologically-confirmed SARS-CoV-2 infection.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 1: Group 5: Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
Serious events: 1 serious events
Other events: 75 other events
Deaths: 0 deaths
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
Serious events: 2 serious events
Other events: 84 other events
Deaths: 0 deaths
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2: Group 11: Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 participants at risk
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 participants at risk
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 participants at risk
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 participants at risk
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nipple Infection
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/85 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Recurrent
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/85 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Missed
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
Other adverse events
| Measure |
Cohort 1: Group 1: SARS-CoV-2 Vaccine LD + AF03
n=36 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 2: SARS-CoV-2 Vaccine LD + AS03
n=36 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 3: SARS-CoV-2 Vaccine HD + AF03
n=35 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1.
|
Cohort 1: Group 4: SARS-CoV-2 Vaccine HD + AS03
n=34 participants at risk
Participants received a single IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1.
|
Cohort 1: Group 5: Placebo
n=34 participants at risk
Participants received a single IM injection of placebo matching to SARS-CoV2 vaccine on Day 1.
|
Cohort 2: Group 6: SARS-CoV-2 Vaccine LD + AF03
n=26 participants at risk
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 7: SARS-CoV-2 Vaccine LD + AS03
n=80 participants at risk
Participants received IM injection of SARS-CoV2 vaccine LD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 8: SARS-CoV-2 Vaccine HD + AF03
n=26 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AF03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 9: SARS-CoV-2 Vaccine HD + AS03
n=85 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation along with adjuvant AS03 on Day 1 and Day 22, respectively.
|
Cohort 2: Group 10: SARS-CoV-2 Vaccine HD
n=18 participants at risk
Participants received IM injection of SARS-CoV2 vaccine HD formulation without adjuvant on Day 1 and Day 22, respectively.
|
Cohort 2: Group 11: Placebo
n=29 participants at risk
Participants received IM injection of placebo matching to SARS-CoV2 vaccine on Day 1 and Day 22, respectively.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
5.6%
2/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
8.8%
3/34 • Number of events 3 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
11.5%
3/26 • Number of events 3 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
23.8%
19/80 • Number of events 20 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
15.4%
4/26 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
45.9%
39/85 • Number of events 41 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.4%
1/29 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Injection Site Pain
|
50.0%
18/36 • Number of events 18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
83.3%
30/36 • Number of events 30 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
60.0%
21/35 • Number of events 21 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
82.4%
28/34 • Number of events 28 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
14.7%
5/34 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
73.1%
19/26 • Number of events 35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
91.2%
73/80 • Number of events 123 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
76.9%
20/26 • Number of events 32 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
94.1%
80/85 • Number of events 142 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
22.2%
4/18 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
20.7%
6/29 • Number of events 7 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/85 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
2/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
10.6%
9/85 • Number of events 9 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.8%
1/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.5%
6/80 • Number of events 7 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
8.2%
7/85 • Number of events 8 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
6.9%
2/29 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Chest Discomfort
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.5%
3/85 • Number of events 3 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.4%
1/29 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Chills
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
16.2%
13/80 • Number of events 14 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
11.8%
10/85 • Number of events 11 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.4%
1/29 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Fatigue
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.7%
2/35 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
6.2%
5/80 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
4.7%
4/85 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Injection Site Discomfort
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/85 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Injection Site Pruritus
|
2.8%
1/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
3/80 • Number of events 3 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
18.8%
16/85 • Number of events 18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Injection Site Swelling
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
2/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.9%
2/34 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
11.5%
3/26 • Number of events 3 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
20.0%
16/80 • Number of events 16 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
15.4%
4/26 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
31.8%
27/85 • Number of events 31 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Malaise
|
16.7%
6/36 • Number of events 6 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
33.3%
12/36 • Number of events 12 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
25.7%
9/35 • Number of events 9 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
23.5%
8/34 • Number of events 8 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
14.7%
5/34 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
57.7%
15/26 • Number of events 17 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
76.2%
61/80 • Number of events 75 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
73.1%
19/26 • Number of events 24 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
80.0%
68/85 • Number of events 88 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
20.7%
6/29 • Number of events 8 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
General disorders
Pyrexia
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
15.4%
4/26 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
35.0%
28/80 • Number of events 30 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
26.9%
7/26 • Number of events 8 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
29.4%
25/85 • Number of events 25 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Investigations
Blood Potassium Increased
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
2/36 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
4.7%
4/85 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.4%
1/29 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
6/36 • Number of events 7 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
33.3%
12/36 • Number of events 12 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
37.1%
13/35 • Number of events 13 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
47.1%
16/34 • Number of events 16 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
17.6%
6/34 • Number of events 6 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
61.5%
16/26 • Number of events 18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
78.8%
63/80 • Number of events 85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
73.1%
19/26 • Number of events 28 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
81.2%
69/85 • Number of events 98 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
16.7%
3/18 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
10.3%
3/29 • Number of events 5 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.9%
2/34 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/85 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
1.2%
1/80 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
5.6%
1/18 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Nervous system disorders
Headache
|
27.8%
10/36 • Number of events 10 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
36.1%
13/36 • Number of events 13 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
11.4%
4/35 • Number of events 4 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
32.4%
11/34 • Number of events 12 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
20.6%
7/34 • Number of events 7 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
53.8%
14/26 • Number of events 18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
75.0%
60/80 • Number of events 81 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
69.2%
18/26 • Number of events 26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
71.8%
61/85 • Number of events 91 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
33.3%
6/18 • Number of events 10 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
24.1%
7/29 • Number of events 11 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.5%
2/80 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
3.8%
1/26 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.4%
2/85 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.4%
2/85 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/35 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/34 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/80 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/36 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/35 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.9%
1/34 • Number of events 1 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
7.7%
2/26 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
2.5%
2/80 • Number of events 2 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/26 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/85 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/18 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
0.00%
0/29 • Unsolicited AE: from Day 0 (pre-vaccination) up to 21 days post any vaccination. Solicited reactions: collected within 7 days post any vaccination. SAE data were collected from Day 1 up to 12 months post last vaccination (i.e., up to Day 366 for Cohort 1 and up to Day 387 for Cohort 2)
SR: defined as an "expected" AR (sign or symptom) observed and reported under conditions prelisted (i.e., solicited) in protocol and CRF and considered as related to vaccination. Unsolicited AE: an observed AE that did not fulfill conditions of solicited reactions prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. SafAS population. In AE section, solicited reaction Fever was reported as Pyrexia. Reported AEs for each arm were presented as pre-specified in protocol.
|
Additional Information
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- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
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