Trial Outcomes & Findings for A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults (NCT NCT05823974)
NCT ID: NCT05823974
Last Updated: 2025-07-23
Results Overview
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
COMPLETED
PHASE1/PHASE2
1275 participants
At Day 29 compared to baseline (Day 1)
2025-07-23
Participant Flow
A total of 1275 participants were included in Enrolled set, out of which only 1256 were included in Exposed set and started the study.
Participant milestones
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
23
|
23
|
22
|
25
|
23
|
22
|
23
|
22
|
23
|
21
|
23
|
115
|
108
|
137
|
120
|
119
|
122
|
125
|
117
|
|
Overall Study
COMPLETED
|
20
|
17
|
18
|
22
|
19
|
21
|
20
|
20
|
20
|
20
|
21
|
21
|
20
|
111
|
105
|
131
|
119
|
116
|
119
|
123
|
116
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
5
|
1
|
3
|
4
|
3
|
2
|
3
|
2
|
2
|
0
|
3
|
4
|
3
|
6
|
1
|
3
|
3
|
2
|
1
|
Reasons for withdrawal
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
1
|
1
|
1
|
0
|
0
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
0
|
2
|
3
|
1
|
1
|
2
|
1
|
1
|
0
|
0
|
1
|
1
|
3
|
0
|
2
|
2
|
0
|
1
|
|
Overall Study
MIGRATED / MOVED FROM THE STUDY AREA
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
1
|
1
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
2
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
Baseline characteristics by cohort
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
Total
n=1256 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18 - 64 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
22 Participants
n=24 Participants
|
23 Participants
n=42 Participants
|
22 Participants
n=42 Participants
|
23 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
23 Participants
n=36 Participants
|
114 Participants
n=36 Participants
|
108 Participants
n=24 Participants
|
137 Participants
n=135 Participants
|
120 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
773 Participants
n=40 Participants
|
|
Age, Customized
65 - 84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
118 Participants
n=44 Participants
|
121 Participants
n=667 Participants
|
124 Participants
n=15 Participants
|
117 Participants
n=40 Participants
|
481 Participants
n=40 Participants
|
|
Age, Customized
≥ 85 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
65 Participants
n=36 Participants
|
55 Participants
n=24 Participants
|
86 Participants
n=135 Participants
|
70 Participants
n=136 Participants
|
69 Participants
n=44 Participants
|
55 Participants
n=667 Participants
|
61 Participants
n=15 Participants
|
71 Participants
n=40 Participants
|
690 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
50 Participants
n=36 Participants
|
53 Participants
n=24 Participants
|
51 Participants
n=135 Participants
|
50 Participants
n=136 Participants
|
50 Participants
n=44 Participants
|
67 Participants
n=667 Participants
|
64 Participants
n=15 Participants
|
46 Participants
n=40 Participants
|
566 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
94 Participants
n=36 Participants
|
91 Participants
n=24 Participants
|
116 Participants
n=135 Participants
|
96 Participants
n=136 Participants
|
88 Participants
n=44 Participants
|
95 Participants
n=667 Participants
|
101 Participants
n=15 Participants
|
87 Participants
n=40 Participants
|
988 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
All other Races
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
19 Participants
n=36 Participants
|
15 Participants
n=24 Participants
|
19 Participants
n=135 Participants
|
17 Participants
n=136 Participants
|
25 Participants
n=44 Participants
|
22 Participants
n=667 Participants
|
19 Participants
n=15 Participants
|
21 Participants
n=40 Participants
|
226 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
5 Participants
n=15 Participants
|
8 Participants
n=40 Participants
|
31 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
UNKNOWN
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the Exposed Set (ES), which included all participants who received a study intervention and for whom solicited administration site events data were available at specified timepoints.
Assessed solicited administration site events included pain, redness (Erythema), swelling, lymphadenopathy (defined as localized axillary, cervical or supraclavicular swelling or tenderness ipsilateral to the injection arm). Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Lymphadenopathy
|
6 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
10 Participants
|
14 Participants
|
5 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
11 Participants
|
2 Participants
|
28 Participants
|
41 Participants
|
53 Participants
|
14 Participants
|
20 Participants
|
19 Participants
|
14 Participants
|
10 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Erythema
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Pain
|
15 Participants
|
19 Participants
|
21 Participants
|
20 Participants
|
19 Participants
|
22 Participants
|
15 Participants
|
19 Participants
|
18 Participants
|
19 Participants
|
21 Participants
|
18 Participants
|
13 Participants
|
82 Participants
|
86 Participants
|
118 Participants
|
53 Participants
|
63 Participants
|
64 Participants
|
78 Participants
|
41 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Adverse Events (AEs)
Swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 7Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom solicited systemic events data were available at specified timepoints.
Assessed solicited systemic events included fever (defined as axillary temperature greater than or equal to (\>=) 38.0°C/100.4°F), chills, headache, fatigue, myalgia, and arthralgia. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic AEs
Arthralgia
|
3 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
11 Participants
|
7 Participants
|
9 Participants
|
10 Participants
|
0 Participants
|
31 Participants
|
37 Participants
|
48 Participants
|
11 Participants
|
15 Participants
|
27 Participants
|
33 Participants
|
9 Participants
|
|
Number of Participants Reporting Any Solicited Systemic AEs
Chills
|
4 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
10 Participants
|
9 Participants
|
15 Participants
|
15 Participants
|
12 Participants
|
12 Participants
|
20 Participants
|
13 Participants
|
0 Participants
|
30 Participants
|
39 Participants
|
73 Participants
|
18 Participants
|
18 Participants
|
19 Participants
|
37 Participants
|
7 Participants
|
|
Number of Participants Reporting Any Solicited Systemic AEs
Fatigue
|
10 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
17 Participants
|
18 Participants
|
16 Participants
|
19 Participants
|
17 Participants
|
16 Participants
|
18 Participants
|
17 Participants
|
9 Participants
|
58 Participants
|
70 Participants
|
103 Participants
|
49 Participants
|
44 Participants
|
51 Participants
|
64 Participants
|
26 Participants
|
|
Number of Participants Reporting Any Solicited Systemic AEs
Headache
|
11 Participants
|
17 Participants
|
15 Participants
|
17 Participants
|
16 Participants
|
17 Participants
|
15 Participants
|
17 Participants
|
14 Participants
|
16 Participants
|
17 Participants
|
13 Participants
|
5 Participants
|
54 Participants
|
58 Participants
|
99 Participants
|
36 Participants
|
36 Participants
|
36 Participants
|
50 Participants
|
19 Participants
|
|
Number of Participants Reporting Any Solicited Systemic AEs
Temperature
|
1 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
25 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
14 Participants
|
2 Participants
|
|
Number of Participants Reporting Any Solicited Systemic AEs
Myalgia
|
10 Participants
|
21 Participants
|
15 Participants
|
18 Participants
|
15 Participants
|
19 Participants
|
15 Participants
|
16 Participants
|
16 Participants
|
18 Participants
|
20 Participants
|
18 Participants
|
9 Participants
|
56 Participants
|
70 Participants
|
98 Participants
|
35 Participants
|
36 Participants
|
40 Participants
|
57 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom unsolicited AEs data were available at specified timepoints.
An unsolicited AE is defined as an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow up for solicited events. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs
|
7 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
4 Participants
|
6 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
34 Participants
|
40 Participants
|
60 Participants
|
45 Participants
|
24 Participants
|
22 Participants
|
28 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom SAEs data were available at specified timepoints.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is an abnormal pregnancy outcome, or is a suspected transmission of any infectious agent via an authorized medicinal product. Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom AESI data were available at specified timepoints.
The following events were considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, myocarditis/pericarditis and potential immune-mediated diseases (pIMDs). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting AEs of Special Interest (AESIs)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 183Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom MAEs data were available at specified timepoints.
MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., physician's office visits, emergency room visits or hospitalization). Any = occurrence the event regardless of intensity grade or relation to the study vaccination.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically Attended Events (MAEs)
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
6 Participants
|
28 Participants
|
28 Participants
|
29 Participants
|
30 Participants
|
20 Participants
|
21 Participants
|
17 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: At Day 8 compared to baseline (Day 1)Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom laboratory data were available at specified timepoints.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Abnormal non-significant to clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 8 for Hematology, and Clinical Chemistry
Normal or missing to clinically significant
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 29 compared to baseline (Day 1)Population: The analysis was performed on the ES, which included all participants who received a study intervention and for whom laboratory data were available for the specified timepoints.
Clinically significant abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participants condition. Normal or missing values refer to laboratory values that were within normal range or missing at baseline.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=20 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Abnormal non-significant to clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting a Shift From Abnormal Non-clinically Significant and Normal or Missing Laboratory Value on Day 1 to Clinically Significant Abnormal Laboratory Value on Day 29 for Hematology, and Clinical Chemistry
Normal or missing to clinically significant
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the Per Protocol Set (PPS), which included all eligible participants who received the study intervention dose according to the protocol, had recorded anti-HI immunogenicity results pre- and post-dose, without intercurrent conditions, and did not use prohibited medications or vaccinations before Day 29 and for whom data were available for the specified analysis at the specified timepoints. Blood sample results that deviated from the analysis criteria were excluded.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=19 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
15.64 Titers
Interval 10.04 to 24.38
|
135.68 Titers
Interval 90.45 to 203.53
|
90.47 Titers
Interval 60.32 to 135.69
|
143.63 Titers
Interval 96.56 to 213.64
|
87.87 Titers
Interval 57.78 to 133.64
|
98.27 Titers
Interval 66.61 to 144.97
|
87.80 Titers
Interval 58.95 to 130.79
|
97.63 Titers
Interval 64.85 to 146.98
|
110.15 Titers
Interval 71.25 to 170.27
|
99.75 Titers
Interval 65.65 to 151.56
|
135.41 Titers
Interval 90.11 to 203.47
|
88.55 Titers
Interval 57.18 to 137.14
|
38.02 Titers
Interval 25.13 to 57.52
|
98.57 Titers
Interval 79.34 to 122.45
|
113.45 Titers
Interval 91.29 to 141.0
|
143.74 Titers
Interval 117.88 to 175.28
|
58.80 Titers
Interval 48.0 to 72.02
|
159.66 Titers
Interval 127.81 to 199.45
|
160.93 Titers
Interval 129.62 to 199.79
|
191.29 Titers
Interval 153.92 to 237.74
|
107.50 Titers
Interval 86.28 to 133.94
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B2 Assay 1
|
240.13 Titers
Interval 184.19 to 313.06
|
689.10 Titers
Interval 540.89 to 877.93
|
536.73 Titers
Interval 421.29 to 683.8
|
727.48 Titers
Interval 573.88 to 922.19
|
739.83 Titers
Interval 576.07 to 950.14
|
689.88 Titers
Interval 547.45 to 869.37
|
536.57 Titers
Interval 422.95 to 680.71
|
568.51 Titers
Interval 445.35 to 725.73
|
624.12 Titers
Interval 481.46 to 809.04
|
617.81 Titers
Interval 481.21 to 793.19
|
534.31 Titers
Interval 418.77 to 681.73
|
501.11 Titers
Interval 386.0 to 650.53
|
764.90 Titers
Interval 596.95 to 980.11
|
605.48 Titers
Interval 534.15 to 686.34
|
692.40 Titers
Interval 610.63 to 785.13
|
687.04 Titers
Interval 613.05 to 769.95
|
913.91 Titers
Interval 813.27 to 1027.0
|
516.25 Titers
Interval 452.96 to 588.38
|
583.05 Titers
Interval 513.21 to 662.39
|
621.87 Titers
Interval 547.3 to 706.61
|
744.28 Titers
Interval 654.26 to 846.7
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
45.65 Titers
Interval 31.51 to 66.12
|
—
|
—
|
—
|
—
|
—
|
—
|
370.16 Titers
Interval 316.87 to 432.43
|
409.56 Titers
Interval 350.4 to 478.7
|
446.20 Titers
Interval 387.24 to 514.14
|
440.96 Titers
Interval 381.0 to 510.34
|
283.03 Titers
Interval 236.19 to 339.15
|
281.44 Titers
Interval 235.95 to 335.72
|
299.04 Titers
Interval 250.56 to 356.9
|
329.89 Titers
Interval 275.95 to 394.36
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
469.49 Titers
Interval 300.51 to 733.47
|
335.19 Titers
Interval 222.96 to 503.91
|
247.82 Titers
Interval 164.81 to 372.65
|
359.26 Titers
Interval 240.96 to 535.62
|
380.39 Titers
Interval 249.53 to 579.9
|
331.81 Titers
Interval 224.48 to 490.45
|
349.06 Titers
Interval 233.45 to 521.94
|
324.35 Titers
Interval 215.04 to 489.23
|
409.93 Titers
Interval 264.86 to 634.45
|
370.39 Titers
Interval 243.46 to 563.51
|
308.20 Titers
Interval 204.25 to 465.06
|
341.20 Titers
Interval 219.93 to 529.33
|
224.76 Titers
Interval 148.16 to 340.98
|
50.99 Titers
Interval 40.14 to 64.76
|
62.65 Titers
Interval 49.16 to 79.83
|
75.46 Titers
Interval 60.58 to 94.01
|
46.97 Titers
Interval 37.55 to 58.75
|
59.83 Titers
Interval 46.9 to 76.33
|
81.06 Titers
Interval 63.87 to 102.88
|
90.00 Titers
Interval 70.89 to 114.26
|
56.52 Titers
Interval 44.51 to 71.77
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
295.42 Titers
Interval 182.26 to 478.85
|
—
|
1545.64 Titers
Interval 921.87 to 2591.47
|
—
|
—
|
—
|
—
|
436.01 Titers
Interval 347.19 to 547.55
|
469.09 Titers
Interval 373.13 to 589.72
|
617.79 Titers
Interval 501.79 to 760.61
|
264.10 Titers
Interval 213.25 to 327.07
|
505.46 Titers
Interval 403.79 to 632.74
|
495.42 Titers
Interval 398.75 to 615.52
|
624.06 Titers
Interval 501.9 to 775.95
|
397.32 Titers
Interval 318.64 to 495.42
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu A1 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
103.70 Titers
Interval 64.91 to 165.68
|
—
|
—
|
—
|
—
|
—
|
—
|
262.86 Titers
Interval 209.06 to 330.49
|
260.70 Titers
Interval 207.26 to 327.92
|
292.27 Titers
Interval 237.21 to 360.11
|
175.58 Titers
Interval 141.75 to 217.49
|
255.17 Titers
Interval 202.02 to 322.31
|
287.14 Titers
Interval 228.87 to 360.24
|
338.20 Titers
Interval 269.1 to 425.06
|
176.21 Titers
Interval 139.85 to 222.01
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
190.37 Titers
Interval 149.51 to 242.41
|
—
|
—
|
—
|
—
|
—
|
—
|
277.45 Titers
Interval 242.32 to 317.66
|
305.19 Titers
Interval 266.47 to 349.53
|
341.88 Titers
Interval 302.03 to 386.98
|
487.32 Titers
Interval 429.42 to 553.02
|
565.86 Titers
Interval 493.2 to 649.22
|
532.34 Titers
Interval 465.9 to 608.25
|
546.58 Titers
Interval 477.99 to 625.02
|
760.08 Titers
Interval 663.75 to 870.39
|
|
Geometric Mean Titer (GMT) of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
74.84 Titers
Interval 56.27 to 99.55
|
149.88 Titers
Interval 115.56 to 194.38
|
154.29 Titers
Interval 118.95 to 200.13
|
168.29 Titers
Interval 130.47 to 217.08
|
160.05 Titers
Interval 122.23 to 209.56
|
150.39 Titers
Interval 117.31 to 192.8
|
123.35 Titers
Interval 95.54 to 159.25
|
151.48 Titers
Interval 116.44 to 197.08
|
133.43 Titers
Interval 133.43 to 176.42
|
139.36 Titers
Interval 106.62 to 182.14
|
151.53 Titers
Interval 116.71 to 196.74
|
161.25 Titers
Interval 120.77 to 215.31
|
208.78 Titers
Interval 158.86 to 274.4
|
97.37 Titers
Interval 80.9 to 117.18
|
114.95 Titers
Interval 95.61 to 138.2
|
125.81 Titers
Interval 106.21 to 149.04
|
200.28 Titers
Interval 168.72 to 237.75
|
173.94 Titers
Interval 148.07 to 204.32
|
184.85 Titers
Interval 158.02 to 216.23
|
193.96 Titers
Interval 165.75 to 226.97
|
258.03 Titers
Interval 220.1 to 302.5
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
GMI is defined as the geometric mean of the ratios of the post dosing titer over the Day 1 titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=19 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu B2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
3.18 Ratio
Interval 2.2 to 4.61
|
—
|
—
|
—
|
—
|
—
|
—
|
1.72 Ratio
Interval 1.47 to 2.01
|
1.90 Ratio
Interval 1.63 to 2.22
|
2.07 Ratio
Interval 1.8 to 2.39
|
2.05 Ratio
Interval 1.77 to 2.37
|
1.39 Ratio
Interval 1.16 to 1.66
|
1.38 Ratio
Interval 1.16 to 1.65
|
1.47 Ratio
Interval 1.23 to 1.75
|
1.62 Ratio
Interval 1.35 to 1.94
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu A1 Assay 1
|
12.83 Ratio
Interval 8.21 to 20.04
|
9.16 Ratio
Interval 6.09 to 13.77
|
6.77 Ratio
Interval 4.5 to 10.18
|
9.81 Ratio
Interval 6.58 to 14.63
|
10.39 Ratio
Interval 6.82 to 15.84
|
9.06 Ratio
Interval 6.13 to 13.4
|
9.54 Ratio
Interval 6.38 to 14.26
|
8.86 Ratio
Interval 5.87 to 13.36
|
11.20 Ratio
Interval 7.24 to 17.33
|
10.12 Ratio
Interval 6.65 to 15.39
|
8.42 Ratio
Interval 5.58 to 12.7
|
9.32 Ratio
Interval 6.01 to 14.46
|
6.14 Ratio
Interval 4.05 to 9.31
|
6.42 Ratio
Interval 5.06 to 8.16
|
7.89 Ratio
Interval 6.19 to 10.06
|
9.51 Ratio
Interval 7.63 to 11.84
|
5.92 Ratio
Interval 4.73 to 7.4
|
6.34 Ratio
Interval 4.97 to 8.09
|
8.59 Ratio
Interval 6.77 to 10.9
|
9.53 Ratio
Interval 7.51 to 12.1
|
5.99 Ratio
Interval 4.72 to 7.6
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu A1 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
6.33 Ratio
Interval 3.96 to 10.12
|
—
|
—
|
—
|
—
|
—
|
—
|
5.36 Ratio
Interval 4.26 to 6.74
|
5.32 Ratio
Interval 4.23 to 6.69
|
5.96 Ratio
Interval 4.84 to 7.35
|
3.58 Ratio
Interval 2.89 to 4.44
|
4.20 Ratio
Interval 3.32 to 5.3
|
4.72 Ratio
Interval 3.76 to 5.92
|
5.56 Ratio
Interval 4.42 to 6.99
|
2.90 Ratio
Interval 2.3 to 3.65
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu A2 Assay 1
|
1.32 Ratio
Interval 0.84 to 2.05
|
11.41 Ratio
Interval 7.6 to 17.11
|
7.61 Ratio
Interval 5.07 to 11.41
|
12.08 Ratio
Interval 8.12 to 17.96
|
7.39 Ratio
Interval 4.86 to 11.24
|
8.26 Ratio
Interval 5.6 to 12.19
|
7.38 Ratio
Interval 4.96 to 11.0
|
8.21 Ratio
Interval 5.45 to 12.36
|
9.26 Ratio
Interval 5.99 to 14.32
|
8.39 Ratio
Interval 5.52 to 12.74
|
11.38 Ratio
Interval 7.58 to 17.11
|
7.44 Ratio
Interval 4.81 to 11.53
|
3.20 Ratio
Interval 2.11 to 4.84
|
6.92 Ratio
Interval 5.57 to 8.6
|
7.96 Ratio
Interval 6.41 to 9.9
|
10.09 Ratio
Interval 8.27 to 12.3
|
4.13 Ratio
Interval 3.37 to 5.06
|
8.35 Ratio
Interval 6.68 to 10.43
|
8.41 Ratio
Interval 6.78 to 10.44
|
10.00 Ratio
Interval 8.05 to 12.43
|
5.62 Ratio
Interval 4.51 to 7.0
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu A2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
4.62 Ratio
Interval 2.85 to 7.48
|
—
|
14.87 Ratio
Interval 8.87 to 24.93
|
—
|
—
|
—
|
—
|
3.75 Ratio
Interval 2.99 to 4.71
|
4.04 Ratio
Interval 3.21 to 5.08
|
5.32 Ratio
Interval 4.32 to 6.55
|
2.27 Ratio
Interval 1.84 to 2.82
|
3.24 Ratio
Interval 2.59 to 4.06
|
3.18 Ratio
Interval 2.56 to 3.95
|
4.00 Ratio
Interval 3.22 to 4.98
|
2.55 Ratio
Interval 2.04 to 3.18
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
1.64 Ratio
Interval 1.29 to 2.09
|
—
|
—
|
—
|
—
|
—
|
—
|
1.40 Ratio
Interval 1.22 to 1.6
|
1.54 Ratio
Interval 1.35 to 1.77
|
1.73 Ratio
Interval 1.53 to 1.95
|
2.46 Ratio
Interval 2.17 to 2.79
|
2.51 Ratio
Interval 2.19 to 2.88
|
2.36 Ratio
Interval 2.07 to 2.7
|
2.43 Ratio
Interval 2.12 to 2.77
|
3.37 Ratio
Interval 2.94 to 3.86
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu B1 Assay 2
|
0.93 Ratio
Interval 0.7 to 1.24
|
1.87 Ratio
Interval 1.44 to 2.42
|
1.92 Ratio
Interval 1.48 to 2.49
|
2.09 Ratio
Interval 1.62 to 2.7
|
1.99 Ratio
Interval 1.52 to 2.61
|
1.87 Ratio
Interval 1.46 to 2.4
|
1.54 Ratio
Interval 1.19 to 1.98
|
1.89 Ratio
Interval 1.45 to 2.45
|
1.66 Ratio
Interval 1.26 to 2.2
|
1.73 Ratio
Interval 1.33 to 2.27
|
1.89 Ratio
Interval 1.45 to 2.45
|
2.01 Ratio
Interval 1.5 to 2.68
|
2.60 Ratio
Interval 1.98 to 3.41
|
1.83 Ratio
Interval 1.52 to 2.2
|
2.16 Ratio
Interval 1.8 to 2.6
|
2.36 Ratio
Interval 2.0 to 2.8
|
3.76 Ratio
Interval 3.17 to 4.47
|
1.77 Ratio
Interval 1.51 to 2.08
|
1.89 Ratio
Interval 1.61 to 2.21
|
1.98 Ratio
Interval 1.69 to 2.32
|
2.63 Ratio
Interval 2.25 to 3.09
|
|
Geometric Mean Increase (GMI) of Antigen 1 Antibody Titers From Day 1 to Day 29
Flu B2 Assay 1
|
1.09 Ratio
Interval 0.84 to 1.42
|
3.13 Ratio
Interval 2.45 to 3.98
|
2.43 Ratio
Interval 1.91 to 3.1
|
3.30 Ratio
Interval 2.6 to 4.18
|
3.36 Ratio
Interval 2.61 to 4.31
|
3.13 Ratio
Interval 2.48 to 3.94
|
2.43 Ratio
Interval 1.92 to 3.09
|
2.58 Ratio
Interval 2.02 to 3.29
|
2.83 Ratio
Interval 2.18 to 3.67
|
2.80 Ratio
Interval 2.18 to 3.6
|
2.42 Ratio
Interval 1.9 to 3.09
|
2.27 Ratio
Interval 1.75 to 2.95
|
3.47 Ratio
Interval 2.71 to 4.45
|
2.04 Ratio
Interval 1.8 to 2.31
|
2.33 Ratio
Interval 2.06 to 2.64
|
2.31 Ratio
Interval 2.06 to 2.59
|
3.08 Ratio
Interval 2.74 to 3.46
|
2.40 Ratio
Interval 2.1 to 2.73
|
2.71 Ratio
Interval 2.38 to 3.08
|
2.89 Ratio
Interval 2.54 to 3.28
|
3.46 Ratio
Interval 3.04 to 3.93
|
PRIMARY outcome
Timeframe: From Day 1 to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
SCR is defined as the percentage of dosed participants who have either an anti-vaccine antibody pre-dose titer \< 1:10 and a post-dose anti-vaccine antibody titer \>= 1:40 or a pre-dose anti-vaccine antibody titer \>= 1:10 and at least a 4-fold increase in post-dose anti-vaccine antibody titer. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=19 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A1 Assay 1
|
78.9 Percentage of participants
Interval 54.4 to 93.9
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
59.1 Percentage of participants
Interval 36.4 to 79.3
|
65.2 Percentage of participants
Interval 42.7 to 83.6
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
70.8 Percentage of participants
Interval 48.9 to 87.4
|
60.9 Percentage of participants
Interval 38.5 to 80.3
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
73.7 Percentage of participants
Interval 48.8 to 90.9
|
81.0 Percentage of participants
Interval 58.1 to 94.6
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
57.9 Percentage of participants
Interval 33.5 to 79.7
|
59.1 Percentage of participants
Interval 36.4 to 79.3
|
49.5 Percentage of participants
Interval 39.4 to 59.6
|
63.8 Percentage of participants
Interval 53.3 to 73.5
|
67.2 Percentage of participants
Interval 58.0 to 75.6
|
47.4 Percentage of participants
Interval 37.9 to 56.9
|
51.4 Percentage of participants
Interval 41.5 to 61.2
|
63.4 Percentage of participants
Interval 53.8 to 72.3
|
64.6 Percentage of participants
Interval 55.0 to 73.4
|
49.5 Percentage of participants
Interval 39.9 to 59.2
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B1 Assay 2
|
0 Percentage of participants
Interval 0.0 to 17.6
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
17.4 Percentage of participants
Interval 5.0 to 38.8
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
4.3 Percentage of participants
Interval 0.1 to 21.9
|
13.6 Percentage of participants
Interval 2.9 to 34.9
|
10.5 Percentage of participants
Interval 1.3 to 33.1
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
18.2 Percentage of participants
Interval 5.2 to 40.3
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
12.9 Percentage of participants
Interval 7.0 to 21.0
|
20.6 Percentage of participants
Interval 13.1 to 30.0
|
19.0 Percentage of participants
Interval 12.4 to 27.1
|
43.9 Percentage of participants
Interval 34.6 to 53.5
|
17.6 Percentage of participants
Interval 10.9 to 26.1
|
22.6 Percentage of participants
Interval 15.3 to 31.3
|
20.9 Percentage of participants
Interval 13.9 to 29.4
|
32.4 Percentage of participants
Interval 23.9 to 42.0
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A1 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
—
|
—
|
—
|
—
|
—
|
—
|
60.4 Percentage of participants
Interval 50.2 to 70.0
|
62.9 Percentage of participants
Interval 52.5 to 72.5
|
62.8 Percentage of participants
Interval 53.6 to 71.4
|
50.0 Percentage of participants
Interval 40.5 to 59.5
|
49.1 Percentage of participants
Interval 39.3 to 58.9
|
59.1 Percentage of participants
Interval 49.6 to 68.2
|
60.9 Percentage of participants
Interval 51.3 to 69.8
|
36.0 Percentage of participants
Interval 27.1 to 45.7
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A2 Assay 1
|
5.3 Percentage of participants
Interval 0.1 to 26.0
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
87.0 Percentage of participants
Interval 66.4 to 97.2
|
71.4 Percentage of participants
Interval 47.8 to 88.7
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
73.9 Percentage of participants
Interval 51.6 to 89.8
|
68.2 Percentage of participants
Interval 45.1 to 86.1
|
68.4 Percentage of participants
Interval 43.4 to 87.4
|
90.5 Percentage of participants
Interval 69.6 to 98.8
|
77.3 Percentage of participants
Interval 54.6 to 92.2
|
47.4 Percentage of participants
Interval 24.4 to 71.1
|
31.8 Percentage of participants
Interval 13.9 to 54.9
|
72.3 Percentage of participants
Interval 62.5 to 80.7
|
70.1 Percentage of participants
Interval 60.0 to 79.0
|
79.3 Percentage of participants
Interval 71.0 to 86.2
|
38.3 Percentage of participants
Interval 29.4 to 47.8
|
62.0 Percentage of participants
Interval 52.2 to 71.2
|
69.0 Percentage of participants
Interval 59.7 to 77.2
|
71.3 Percentage of participants
Interval 62.1 to 79.4
|
54.1 Percentage of participants
Interval 44.3 to 63.6
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu A2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
65.2 Percentage of participants
Interval 42.7 to 83.6
|
—
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
—
|
—
|
—
|
—
|
54.5 Percentage of participants
Interval 44.2 to 64.4
|
49.5 Percentage of participants
Interval 39.2 to 59.8
|
63.6 Percentage of participants
Interval 54.4 to 72.2
|
37.7 Percentage of participants
Interval 28.8 to 47.3
|
43.5 Percentage of participants
Interval 34.0 to 53.4
|
52.2 Percentage of participants
Interval 42.7 to 61.6
|
53.9 Percentage of participants
Interval 44.4 to 63.2
|
38.7 Percentage of participants
Interval 29.6 to 48.5
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
12.9 Percentage of participants
Interval 7.0 to 21.0
|
12.4 Percentage of participants
Interval 6.6 to 20.6
|
17.4 Percentage of participants
Interval 11.1 to 25.3
|
32.2 Percentage of participants
Interval 23.8 to 41.5
|
28.7 Percentage of participants
Interval 20.4 to 38.2
|
27.6 Percentage of participants
Interval 19.7 to 36.7
|
29.6 Percentage of participants
Interval 21.4 to 38.8
|
41.4 Percentage of participants
Interval 32.2 to 51.2
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B2 Assay 1
|
0 Percentage of participants
Interval 0.0 to 17.6
|
36.4 Percentage of participants
Interval 17.2 to 59.3
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
52.2 Percentage of participants
Interval 30.6 to 73.2
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
33.3 Percentage of participants
Interval 15.6 to 55.3
|
26.1 Percentage of participants
Interval 10.2 to 48.4
|
18.2 Percentage of participants
Interval 5.2 to 40.3
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
15.8 Percentage of participants
Interval 3.4 to 39.6
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
25.7 Percentage of participants
Interval 17.6 to 35.4
|
26.0 Percentage of participants
Interval 17.6 to 36.0
|
23.1 Percentage of participants
Interval 16.0 to 31.7
|
36.5 Percentage of participants
Interval 27.7 to 46.0
|
38.0 Percentage of participants
Interval 28.8 to 47.8
|
38.8 Percentage of participants
Interval 29.9 to 48.3
|
40.9 Percentage of participants
Interval 31.8 to 50.4
|
39.6 Percentage of participants
Interval 30.5 to 49.4
|
|
Percentage of Participants With Antigen 1 Antibody Seroconversion Rate (SCR)
Flu B2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
26.1 Percentage of participants
Interval 10.2 to 48.4
|
—
|
—
|
—
|
—
|
—
|
—
|
17.8 Percentage of participants
Interval 10.9 to 26.7
|
21.6 Percentage of participants
Interval 13.9 to 31.2
|
24.0 Percentage of participants
Interval 16.7 to 32.6
|
21.9 Percentage of participants
Interval 14.7 to 30.6
|
17.6 Percentage of participants
Interval 10.9 to 26.1
|
20.0 Percentage of participants
Interval 13.1 to 28.5
|
17.4 Percentage of participants
Interval 11.0 to 25.6
|
23.4 Percentage of participants
Interval 15.9 to 32.4
|
PRIMARY outcome
Timeframe: At Day 1Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
SPR is defined as the percentage of dosed participants with a anti-vaccine antibody titer \>= 1:40. Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=20 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=102 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=99 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=125 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=116 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=117 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=119 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B1 Assay 2
|
85.0 Percentage of participants
Interval 62.1 to 96.8
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
86.4 Percentage of participants
Interval 65.1 to 97.1
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
76.2 Percentage of participants
Interval 52.8 to 91.8
|
91.7 Percentage of participants
Interval 73.0 to 99.0
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100 Percentage of participants
Interval 83.9 to 100.0
|
76.2 Percentage of participants
Interval 52.8 to 91.8
|
100 Percentage of participants
Interval 84.6 to 100.0
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
85.7 Percentage of participants
Interval 63.7 to 97.0
|
71.6 Percentage of participants
Interval 61.8 to 80.1
|
68.7 Percentage of participants
Interval 58.6 to 77.6
|
62.4 Percentage of participants
Interval 53.3 to 70.9
|
63.8 Percentage of participants
Interval 54.4 to 72.5
|
83.6 Percentage of participants
Interval 75.4 to 90.0
|
81.2 Percentage of participants
Interval 72.9 to 87.8
|
84.9 Percentage of participants
Interval 77.2 to 90.8
|
86.3 Percentage of participants
Interval 78.7 to 92.0
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B2 Assay 1
|
100 Percentage of participants
Interval 83.2 to 100.0
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
97.1 Percentage of participants
Interval 91.6 to 99.4
|
100 Percentage of participants
Interval 96.3 to 100.0
|
100 Percentage of participants
Interval 97.1 to 100.0
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
95.5 Percentage of participants
Interval 89.7 to 98.5
|
98.3 Percentage of participants
Interval 94.0 to 99.8
|
97.5 Percentage of participants
Interval 92.8 to 99.5
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
26.1 Percentage of participants
Interval 10.2 to 48.4
|
—
|
—
|
—
|
—
|
—
|
—
|
98.0 Percentage of participants
Interval 93.1 to 99.8
|
96.0 Percentage of participants
Interval 90.0 to 98.9
|
97.6 Percentage of participants
Interval 93.1 to 99.5
|
98.3 Percentage of participants
Interval 93.9 to 99.8
|
96.4 Percentage of participants
Interval 91.0 to 99.0
|
95.7 Percentage of participants
Interval 90.3 to 98.6
|
95.0 Percentage of participants
Interval 89.3 to 98.1
|
98.3 Percentage of participants
Interval 94.0 to 99.8
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A1 Assay 1
|
60.0 Percentage of participants
Interval 36.1 to 80.9
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
50.0 Percentage of participants
Interval 28.2 to 71.8
|
65.2 Percentage of participants
Interval 42.7 to 83.6
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
37.5 Percentage of participants
Interval 18.8 to 59.4
|
69.6 Percentage of participants
Interval 47.1 to 86.8
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
66.7 Percentage of participants
Interval 43.0 to 85.4
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
45.5 Percentage of participants
Interval 24.4 to 67.8
|
47.6 Percentage of participants
Interval 25.7 to 70.2
|
45.5 Percentage of participants
Interval 24.4 to 67.8
|
13.7 Percentage of participants
Interval 7.7 to 22.0
|
8.3 Percentage of participants
Interval 3.7 to 15.8
|
7.3 Percentage of participants
Interval 3.4 to 13.4
|
9.6 Percentage of participants
Interval 4.9 to 16.5
|
13.6 Percentage of participants
Interval 7.8 to 21.5
|
14.9 Percentage of participants
Interval 8.9 to 22.8
|
8.6 Percentage of participants
Interval 4.2 to 15.3
|
16.2 Percentage of participants
Interval 10.1 to 24.2
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A1 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
—
|
—
|
—
|
—
|
—
|
—
|
70.6 Percentage of participants
Interval 60.7 to 79.2
|
71.7 Percentage of participants
Interval 61.8 to 80.3
|
66.4 Percentage of participants
Interval 57.4 to 74.6
|
60.3 Percentage of participants
Interval 50.8 to 69.3
|
84.5 Percentage of participants
Interval 76.4 to 90.7
|
71.8 Percentage of participants
Interval 62.7 to 79.7
|
65.5 Percentage of participants
Interval 56.3 to 74.0
|
88.9 Percentage of participants
Interval 81.7 to 93.9
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A2 Assay 1
|
20.0 Percentage of participants
Interval 5.7 to 43.7
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
22.7 Percentage of participants
Interval 7.8 to 45.4
|
13.0 Percentage of participants
Interval 2.8 to 33.6
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
8.3 Percentage of participants
Interval 1.0 to 27.0
|
26.1 Percentage of participants
Interval 10.2 to 48.4
|
36.4 Percentage of participants
Interval 17.2 to 59.3
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
18.6 Percentage of participants
Interval 11.6 to 27.6
|
22.2 Percentage of participants
Interval 14.5 to 31.7
|
21.6 Percentage of participants
Interval 14.7 to 29.8
|
32.8 Percentage of participants
Interval 24.3 to 42.1
|
38.2 Percentage of participants
Interval 29.1 to 47.9
|
30.8 Percentage of participants
Interval 22.6 to 40.0
|
31.9 Percentage of participants
Interval 23.7 to 41.1
|
32.5 Percentage of participants
Interval 24.1 to 41.8
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu A2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
78.3 Percentage of participants
Interval 56.3 to 92.5
|
—
|
81.0 Percentage of participants
Interval 58.1 to 94.6
|
—
|
—
|
—
|
—
|
78.4 Percentage of participants
Interval 69.2 to 86.0
|
78.8 Percentage of participants
Interval 69.4 to 86.4
|
77.6 Percentage of participants
Interval 69.3 to 84.6
|
82.8 Percentage of participants
Interval 74.6 to 89.1
|
91.8 Percentage of participants
Interval 85.0 to 96.2
|
86.3 Percentage of participants
Interval 78.7 to 92.0
|
82.4 Percentage of participants
Interval 74.3 to 88.7
|
88.9 Percentage of participants
Interval 81.7 to 93.9
|
|
Percentage of Participants With Antigen 1 Antibody Seroprotection Rate (SPR)
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
97.1 Percentage of participants
Interval 91.6 to 99.4
|
98.0 Percentage of participants
Interval 92.9 to 99.8
|
98.4 Percentage of participants
Interval 94.3 to 99.8
|
96.6 Percentage of participants
Interval 91.4 to 99.1
|
93.6 Percentage of participants
Interval 87.3 to 97.4
|
94.9 Percentage of participants
Interval 89.2 to 98.1
|
99.2 Percentage of participants
Interval 95.4 to 100.0
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=19 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=24 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
94.7 Percentage of participants
Interval 74.0 to 99.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
95.8 Percentage of participants
Interval 78.9 to 99.9
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
94.7 Percentage of participants
Interval 74.0 to 99.9
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100 Percentage of participants
Interval 82.4 to 100.0
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
55.4 Percentage of participants
Interval 45.2 to 65.3
|
65.6 Percentage of participants
Interval 55.2 to 75.0
|
73.3 Percentage of participants
Interval 64.5 to 81.0
|
63.5 Percentage of participants
Interval 54.0 to 72.3
|
64.5 Percentage of participants
Interval 54.6 to 73.5
|
72.3 Percentage of participants
Interval 63.1 to 80.4
|
71.3 Percentage of participants
Interval 62.1 to 79.4
|
69.4 Percentage of participants
Interval 59.9 to 77.8
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
82.6 Percentage of participants
Interval 61.2 to 95.0
|
—
|
—
|
—
|
—
|
—
|
—
|
95.0 Percentage of participants
Interval 88.8 to 98.4
|
95.9 Percentage of participants
Interval 89.8 to 98.9
|
99.2 Percentage of participants
Interval 95.5 to 100.0
|
87.7 Percentage of participants
Interval 80.3 to 93.1
|
97.2 Percentage of participants
Interval 92.1 to 99.4
|
94.8 Percentage of participants
Interval 89.0 to 98.1
|
96.5 Percentage of participants
Interval 91.3 to 99.0
|
90.1 Percentage of participants
Interval 83.0 to 94.9
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
31.6 Percentage of participants
Interval 12.6 to 56.6
|
100 Percentage of participants
Interval 84.6 to 100.0
|
72.7 Percentage of participants
Interval 49.8 to 89.3
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
90.5 Percentage of participants
Interval 69.6 to 98.8
|
79.2 Percentage of participants
Interval 57.8 to 92.9
|
82.6 Percentage of participants
Interval 61.2 to 95.0
|
90.9 Percentage of participants
Interval 70.8 to 98.9
|
89.5 Percentage of participants
Interval 66.9 to 98.7
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
86.4 Percentage of participants
Interval 65.1 to 97.1
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
59.1 Percentage of participants
Interval 36.4 to 79.3
|
83.2 Percentage of participants
Interval 74.4 to 89.9
|
83.5 Percentage of participants
Interval 74.6 to 90.3
|
92.6 Percentage of participants
Interval 86.3 to 96.5
|
69.6 Percentage of participants
Interval 60.3 to 77.8
|
88.0 Percentage of participants
Interval 80.3 to 93.4
|
86.2 Percentage of participants
Interval 78.6 to 91.9
|
90.4 Percentage of participants
Interval 83.5 to 95.1
|
81.1 Percentage of participants
Interval 72.5 to 87.9
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 85.2 to 100.0
|
—
|
100 Percentage of participants
Interval 82.4 to 100.0
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 96.4 to 100.0
|
99.0 Percentage of participants
Interval 94.4 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
98.2 Percentage of participants
Interval 93.8 to 99.8
|
100 Percentage of participants
Interval 96.6 to 100.0
|
98.3 Percentage of participants
Interval 93.9 to 99.8
|
100 Percentage of participants
Interval 96.8 to 100.0
|
97.3 Percentage of participants
Interval 92.3 to 99.4
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
99.0 Percentage of participants
Interval 94.6 to 100.0
|
97.9 Percentage of participants
Interval 92.7 to 99.7
|
99.2 Percentage of participants
Interval 95.5 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.6 to 100.0
|
100 Percentage of participants
Interval 96.9 to 100.0
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
100 Percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
100 Percentage of participants
Interval 86.6 to 100.0
|
95.4 Percentage of participants
Interval 77.2 to 99.9
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 82.4 to 100.0
|
95.2 Percentage of participants
Interval 76.2 to 99.9
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 82.4 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
82.2 Percentage of participants
Interval 73.3 to 89.1
|
83.5 Percentage of participants
Interval 74.6 to 90.3
|
83.5 Percentage of participants
Interval 75.6 to 89.6
|
95.6 Percentage of participants
Interval 90.1 to 98.6
|
97.2 Percentage of participants
Interval 92.1 to 99.4
|
96.5 Percentage of participants
Interval 91.3 to 99.0
|
97.4 Percentage of participants
Interval 92.6 to 99.5
|
100 Percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B2 Assay 1
|
100 Percentage of participants
Interval 82.4 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 85.8 to 100.0
|
100 Percentage of participants
Interval 85.2 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 82.4 to 100.0
|
100 Percentage of participants
Interval 83.9 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 82.4 to 100.0
|
100 Percentage of participants
Interval 84.6 to 100.0
|
100 Percentage of participants
Interval 96.4 to 100.0
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.6 to 100.0
|
100 Percentage of participants
Interval 96.9 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.7 to 100.0
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B2 Assay 2
|
—
|
—
|
—
|
—
|
—
|
—
|
56.5 Percentage of participants
Interval 34.5 to 76.8
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 96.4 to 100.0
|
99.0 Percentage of participants
Interval 94.4 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
98.2 Percentage of participants
Interval 93.6 to 99.8
|
PRIMARY outcome
Timeframe: At Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Antigen 2 Antibody Titer
Flu B1
|
—
|
—
|
—
|
—
|
—
|
—
|
1494.07 Titers
Interval 1135.89 to 1965.2
|
2122.26 Titers
Interval 1599.71 to 2815.5
|
1693.64 Titers
Interval 1259.15 to 2278.06
|
1673.20 Titers
Interval 1256.77 to 2227.62
|
1459.78 Titers
Interval 1103.36 to 1931.34
|
1903.93 Titers
Interval 1409.82 to 2571.23
|
926.76 Titers
Interval 692.23 to 1240.76
|
591.78 Titers
Interval 519.62 to 673.97
|
696.93 Titers
Interval 612.01 to 793.65
|
763.06 Titers
Interval 677.81 to 859.03
|
376.75 Titers
Interval 333.71 to 425.33
|
719.59 Titers
Interval 624.28 to 829.45
|
759.26 Titers
Interval 661.67 to 871.25
|
941.93 Titers
Interval 819.5 to 1082.65
|
483.95 Titers
Interval 420.71 to 556.7
|
|
GMT of Antigen 2 Antibody Titer
Flu B2
|
—
|
—
|
—
|
—
|
—
|
—
|
2566.54 Titers
Interval 1990.57 to 3309.17
|
3373.58 Titers
Interval 2593.73 to 4387.9
|
3214.91 Titers
Interval 2441.12 to 4233.98
|
3281.89 Titers
Interval 2515.38 to 4281.98
|
2614.82 Titers
Interval 2016.67 to 3390.38
|
3204.51 Titers
Interval 2412.86 to 4255.89
|
1424.37 Titers
Interval 1086.67 to 1867.01
|
2600.03 Titers
Interval 2325.91 to 2906.44
|
2911.06 Titers
Interval 2600.25 to 3259.02
|
3171.75 Titers
Interval 2863.73 to 3512.9
|
1267.32 Titers
Interval 1141.86 to 1406.56
|
3405.35 Titers
Interval 3042.32 to 3811.71
|
3653.30 Titers
Interval 3274.24 to 4076.25
|
4243.16 Titers
Interval 3798.55 to 4739.81
|
1999.75 Titers
Interval 1788.7 to 2235.72
|
|
GMT of Antigen 2 Antibody Titer
Flu A1
|
—
|
—
|
—
|
—
|
—
|
—
|
5588.80 Titers
Interval 4242.15 to 7362.94
|
4087.84 Titers
Interval 3073.11 to 5437.63
|
4140.51 Titers
Interval 3070.75 to 5582.93
|
5830.63 Titers
Interval 4362.9 to 7792.13
|
5311.18 Titers
Interval 4005.78 to 7041.98
|
6374.69 Titers
Interval 4720.97 to 8607.68
|
1126.63 Titers
Interval 840.59 to 1510.0
|
763.90 Titers
Interval 652.5 to 894.32
|
940.60 Titers
Interval 802.48 to 1102.49
|
988.40 Titers
Interval 855.52 to 1141.91
|
151.87 Titers
Interval 131.07 to 175.97
|
863.96 Titers
Interval 733.17 to 1018.07
|
835.61 Titers
Interval 712.72 to 979.69
|
1159.00 Titers
Interval 987.31 to 1360.55
|
194.60 Titers
Interval 165.47 to 228.85
|
|
GMT of Antigen 2 Antibody Titer
Flu A2
|
—
|
—
|
—
|
—
|
—
|
—
|
782.28 Titers
Interval 634.47 to 964.53
|
974.11 Titers
Interval 783.89 to 1210.5
|
755.19 Titers
Interval 602.64 to 946.35
|
868.89 Titers
Interval 694.91 to 1086.43
|
984.15 Titers
Interval 794.34 to 1219.31
|
1137.13 Titers
Interval 902.89 to 1432.13
|
424.76 Titers
Interval 339.51 to 531.43
|
778.89 Titers
Interval 686.52 to 883.69
|
920.46 Titers
Interval 810.96 to 1044.75
|
1070.07 Titers
Interval 952.77 to 1201.82
|
369.35 Titers
Interval 328.29 to 415.54
|
1107.49 Titers
Interval 967.9 to 1267.21
|
1156.39 Titers
Interval 1014.68 to 1317.91
|
1355.41 Titers
Interval 1188.24 to 1546.1
|
504.28 Titers
Interval 441.44 to 576.06
|
PRIMARY outcome
Timeframe: From Day 1 (baseline) to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Flu A1
|
—
|
—
|
—
|
—
|
—
|
—
|
6.99 Ratio
Interval 5.31 to 9.22
|
5.12 Ratio
Interval 3.85 to 6.81
|
5.18 Ratio
Interval 3.84 to 6.99
|
7.30 Ratio
Interval 5.46 to 9.75
|
6.65 Ratio
Interval 5.01 to 8.81
|
7.98 Ratio
Interval 5.91 to 10.77
|
1.41 Ratio
Interval 1.05 to 1.89
|
6.37 Ratio
Interval 5.44 to 7.45
|
7.84 Ratio
Interval 6.69 to 9.19
|
8.24 Ratio
Interval 7.13 to 9.52
|
1.27 Ratio
Interval 1.09 to 1.47
|
6.06 Ratio
Interval 5.14 to 7.14
|
5.86 Ratio
Interval 5.0 to 6.87
|
8.13 Ratio
Interval 6.92 to 9.54
|
1.36 Ratio
Interval 1.16 to 1.6
|
|
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Flu A2
|
—
|
—
|
—
|
—
|
—
|
—
|
4.00 Ratio
Interval 3.24 to 4.93
|
4.98 Ratio
Interval 4.01 to 6.19
|
3.86 Ratio
Interval 3.08 to 4.84
|
4.44 Ratio
Interval 3.55 to 5.56
|
5.03 Ratio
Interval 4.06 to 6.24
|
5.82 Ratio
Interval 4.62 to 7.32
|
2.17 Ratio
Interval 1.74 to 2.72
|
3.25 Ratio
Interval 2.87 to 3.69
|
3.84 Ratio
Interval 3.39 to 4.36
|
4.47 Ratio
Interval 3.98 to 5.02
|
1.54 Ratio
Interval 1.37 to 1.74
|
3.34 Ratio
Interval 2.92 to 3.82
|
3.49 Ratio
Interval 3.06 to 3.98
|
4.09 Ratio
Interval 3.59 to 4.67
|
1.52 Ratio
Interval 1.33 to 1.74
|
|
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Flu B1
|
—
|
—
|
—
|
—
|
—
|
—
|
4.82 Ratio
Interval 3.66 to 6.34
|
6.85 Ratio
Interval 5.16 to 9.08
|
5.46 Ratio
Interval 4.06 to 7.35
|
5.40 Ratio
Interval 4.05 to 7.19
|
4.71 Ratio
Interval 3.56 to 6.23
|
6.14 Ratio
Interval 4.55 to 8.3
|
2.99 Ratio
Interval 2.23 to 4.0
|
3.54 Ratio
Interval 3.11 to 4.04
|
4.17 Ratio
Interval 3.67 to 4.75
|
4.57 Ratio
Interval 4.06 to 5.14
|
2.26 Ratio
Interval 2.0 to 2.55
|
3.05 Ratio
Interval 2.65 to 3.52
|
3.22 Ratio
Interval 2.81 to 3.7
|
4.00 Ratio
Interval 3.48 to 4.6
|
2.05 Ratio
Interval 1.79 to 2.36
|
|
GMI of Antigen 2 Antibody Titer From Day 1 to Day 29
Flu B2
|
—
|
—
|
—
|
—
|
—
|
—
|
4.82 Ratio
Interval 3.74 to 6.22
|
6.34 Ratio
Interval 4.87 to 8.25
|
6.04 Ratio
Interval 4.59 to 7.96
|
6.17 Ratio
Interval 4.73 to 8.05
|
4.91 Ratio
Interval 3.79 to 6.37
|
6.02 Ratio
Interval 4.53 to 8.0
|
2.68 Ratio
Interval 2.04 to 3.51
|
3.72 Ratio
Interval 3.33 to 4.16
|
4.16 Ratio
Interval 3.72 to 4.66
|
4.54 Ratio
Interval 4.1 to 5.02
|
1.81 Ratio
Interval 1.63 to 2.01
|
3.57 Ratio
Interval 3.19 to 4.0
|
3.83 Ratio
Interval 3.44 to 4.28
|
4.45 Ratio
Interval 3.99 to 4.97
|
2.10 Ratio
Interval 1.88 to 2.35
|
PRIMARY outcome
Timeframe: From Day 1 to Day 29Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=19 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=22 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=101 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=97 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=121 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=115 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=108 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=116 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=115 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=111 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antigen 2 Antibody SCR
Flu A1
|
—
|
—
|
—
|
—
|
—
|
—
|
73.9 Percentage of participants
Interval 51.6 to 89.8
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
63.2 Percentage of participants
Interval 38.4 to 83.7
|
76.2 Percentage of participants
Interval 52.8 to 91.8
|
86.4 Percentage of participants
Interval 65.1 to 97.1
|
78.9 Percentage of participants
Interval 54.4 to 93.9
|
9.1 Percentage of participants
Interval 1.1 to 29.2
|
68.3 Percentage of participants
Interval 58.3 to 77.2
|
77.3 Percentage of participants
Interval 67.7 to 85.2
|
77.7 Percentage of participants
Interval 69.2 to 84.8
|
3.5 Percentage of participants
Interval 1.0 to 8.7
|
58.3 Percentage of participants
Interval 48.5 to 67.7
|
61.2 Percentage of participants
Interval 51.7 to 70.1
|
72.2 Percentage of participants
Interval 63.0 to 80.1
|
5.4 Percentage of participants
Interval 2.0 to 11.4
|
|
Percentage of Participants With Antigen 2 Antibody SCR
Flu A2
|
—
|
—
|
—
|
—
|
—
|
—
|
39.1 Percentage of participants
Interval 19.7 to 61.5
|
50.0 Percentage of participants
Interval 28.2 to 71.8
|
52.6 Percentage of participants
Interval 28.9 to 75.6
|
66.7 Percentage of participants
Interval 43.0 to 85.4
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
63.2 Percentage of participants
Interval 38.4 to 83.7
|
18.2 Percentage of participants
Interval 5.2 to 40.3
|
32.7 Percentage of participants
Interval 23.7 to 42.7
|
46.4 Percentage of participants
Interval 36.2 to 56.8
|
50.4 Percentage of participants
Interval 41.2 to 59.6
|
7.0 Percentage of participants
Interval 3.1 to 13.2
|
38.9 Percentage of participants
Interval 29.7 to 48.7
|
40.5 Percentage of participants
Interval 31.5 to 50.0
|
45.2 Percentage of participants
Interval 35.9 to 54.8
|
6.3 Percentage of participants
Interval 2.6 to 12.6
|
|
Percentage of Participants With Antigen 2 Antibody SCR
Flu B1
|
—
|
—
|
—
|
—
|
—
|
—
|
69.6 Percentage of participants
Interval 47.1 to 86.8
|
77.3 Percentage of participants
Interval 54.6 to 92.2
|
57.9 Percentage of participants
Interval 33.5 to 79.7
|
57.1 Percentage of participants
Interval 34.0 to 78.2
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
63.2 Percentage of participants
Interval 38.4 to 83.7
|
45.5 Percentage of participants
Interval 24.4 to 67.8
|
38.6 Percentage of participants
Interval 29.1 to 48.8
|
50.5 Percentage of participants
Interval 40.2 to 60.8
|
61.2 Percentage of participants
Interval 51.9 to 69.9
|
24.3 Percentage of participants
Interval 16.8 to 33.2
|
39.8 Percentage of participants
Interval 30.5 to 49.7
|
35.3 Percentage of participants
Interval 26.7 to 44.8
|
48.7 Percentage of participants
Interval 39.3 to 58.2
|
18.9 Percentage of participants
Interval 12.1 to 27.5
|
|
Percentage of Participants With Antigen 2 Antibody SCR
Flu B2
|
—
|
—
|
—
|
—
|
—
|
—
|
69.6 Percentage of participants
Interval 47.1 to 86.8
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
57.9 Percentage of participants
Interval 33.5 to 79.7
|
61.9 Percentage of participants
Interval 38.4 to 81.9
|
54.5 Percentage of participants
Interval 32.2 to 75.6
|
61.1 Percentage of participants
Interval 35.7 to 82.7
|
27.3 Percentage of participants
Interval 10.7 to 50.2
|
43.6 Percentage of participants
Interval 33.7 to 53.8
|
49.0 Percentage of participants
Interval 38.6 to 59.4
|
58.3 Percentage of participants
Interval 49.0 to 67.3
|
5.2 Percentage of participants
Interval 1.9 to 11.0
|
34.3 Percentage of participants
Interval 25.4 to 44.0
|
44.8 Percentage of participants
Interval 35.6 to 54.3
|
51.3 Percentage of participants
Interval 41.8 to 60.7
|
13.5 Percentage of participants
Interval 7.8 to 21.3
|
SECONDARY outcome
Timeframe: At Day 92Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=20 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=20 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=89 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=117 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=112 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=105 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=111 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=109 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
249.15 Titers
Interval 173.16 to 358.51
|
192.79 Titers
Interval 137.06 to 271.19
|
141.86 Titers
Interval 99.24 to 202.76
|
170.29 Titers
Interval 120.34 to 240.99
|
180.99 Titers
Interval 126.21 to 259.54
|
161.89 Titers
Interval 113.44 to 231.04
|
162.26 Titers
Interval 114.31 to 230.34
|
181.10 Titers
Interval 126.57 to 259.12
|
189.92 Titers
Interval 133.06 to 271.09
|
186.49 Titers
Interval 130.23 to 267.06
|
139.19 Titers
Interval 98.69 to 196.29
|
157.89 Titers
Interval 111.25 to 224.09
|
175.06 Titers
Interval 121.7 to 251.82
|
35.51 Titers
Interval 28.05 to 44.94
|
42.16 Titers
Interval 33.07 to 53.73
|
49.93 Titers
Interval 40.3 to 61.86
|
32.01 Titers
Interval 25.76 to 39.78
|
45.30 Titers
Interval 35.89 to 57.19
|
56.56 Titers
Interval 44.85 to 71.32
|
54.03 Titers
Interval 42.88 to 68.08
|
37.38 Titers
Interval 29.75 to 46.96
|
|
GMT of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
11.75 Titers
Interval 8.22 to 16.8
|
55.13 Titers
Interval 39.43 to 77.07
|
29.95 Titers
Interval 21.1 to 42.51
|
54.66 Titers
Interval 38.86 to 76.87
|
29.31 Titers
Interval 20.58 to 41.75
|
60.28 Titers
Interval 42.5 to 85.51
|
39.46 Titers
Interval 28.02 to 55.57
|
44.27 Titers
Interval 31.12 to 62.96
|
43.27 Titers
Interval 30.52 to 61.35
|
40.37 Titers
Interval 28.34 to 57.49
|
55.76 Titers
Interval 39.85 to 78.03
|
36.29 Titers
Interval 25.74 to 51.18
|
18.15 Titers
Interval 12.71 to 25.93
|
64.25 Titers
Interval 52.6 to 78.47
|
71.59 Titers
Interval 58.44 to 87.71
|
83.99 Titers
Interval 70.12 to 100.61
|
39.61 Titers
Interval 32.95 to 47.61
|
102.19 Titers
Interval 83.56 to 124.97
|
106.65 Titers
Interval 87.44 to 130.09
|
113.92 Titers
Interval 93.61 to 138.65
|
71.02 Titers
Interval 58.29 to 86.54
|
|
GMT of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
357.44 Titers
Interval 312.2 to 409.25
|
370.02 Titers
Interval 322.42 to 424.65
|
399.21 Titers
Interval 353.18 to 451.22
|
455.96 Titers
Interval 402.5 to 516.53
|
522.16 Titers
Interval 463.42 to 588.34
|
506.16 Titers
Interval 450.05 to 569.26
|
521.79 Titers
Interval 464.51 to 586.13
|
710.33 Titers
Interval 631.89 to 798.49
|
|
GMT of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
103.58 Titers
Interval 81.09 to 132.31
|
181.64 Titers
Interval 144.48 to 228.36
|
166.80 Titers
Interval 131.32 to 211.86
|
190.14 Titers
Interval 150.62 to 240.03
|
205.33 Titers
Interval 160.99 to 261.88
|
159.14 Titers
Interval 125.44 to 201.9
|
155.71 Titers
Interval 123.25 to 196.74
|
200.39 Titers
Interval 157.48 to 254.99
|
187.72 Titers
Interval 147.77 to 238.47
|
178.11 Titers
Interval 139.79 to 226.92
|
204.04 Titers
Interval 162.18 to 256.71
|
184.58 Titers
Interval 144.99 to 234.99
|
282.65 Titers
Interval 219.83 to 363.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMT of Antigen 1 Antibody Titer
Flu B2 Assay 1
|
219.10 Titers
Interval 169.39 to 283.39
|
502.03 Titers
Interval 394.47 to 638.93
|
383.24 Titers
Interval 297.89 to 493.04
|
467.42 Titers
Interval 365.66 to 597.49
|
537.37 Titers
Interval 416.59 to 693.16
|
463.98 Titers
Interval 361.11 to 596.16
|
405.98 Titers
Interval 317.33 to 519.4
|
544.86 Titers
Interval 423.01 to 701.82
|
486.21 Titers
Interval 377.94 to 625.49
|
441.71 Titers
Interval 342.34 to 569.94
|
446.45 Titers
Interval 350.33 to 568.95
|
442.34 Titers
Interval 345.41 to 566.47
|
722.16 Titers
Interval 558.36 to 934.02
|
480.70 Titers
Interval 413.79 to 558.42
|
520.76 Titers
Interval 446.98 to 606.72
|
571.84 Titers
Interval 499.62 to 654.49
|
716.31 Titers
Interval 624.19 to 822.04
|
440.05 Titers
Interval 388.12 to 498.93
|
473.09 Titers
Interval 417.8 to 535.69
|
499.32 Titers
Interval 441.83 to 564.29
|
599.30 Titers
Interval 529.97 to 677.69
|
SECONDARY outcome
Timeframe: At Day 183Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=18 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=16 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=18 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=15 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=95 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=120 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=113 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=103 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=112 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=113 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Antigen 1 Antibody Titer
Flu B1 Assay 2
|
121.95 Titers
Interval 93.94 to 158.3
|
159.09 Titers
Interval 120.22 to 210.51
|
154.88 Titers
Interval 117.1 to 204.85
|
165.36 Titers
Interval 129.73 to 210.77
|
142.31 Titers
Interval 108.8 to 186.16
|
146.00 Titers
Interval 111.32 to 191.48
|
161.31 Titers
Interval 121.84 to 213.56
|
208.89 Titers
Interval 157.25 to 277.48
|
166.40 Titers
Interval 130.45 to 212.26
|
196.59 Titers
Interval 150.49 to 256.81
|
163.74 Titers
Interval 128.14 to 209.21
|
171.47 Titers
Interval 131.44 to 223.7
|
210.29 Titers
Interval 156.09 to 283.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMT of Antigen 1 Antibody Titer
Flu A1 Assay 1
|
124.39 Titers
Interval 82.01 to 188.69
|
118.75 Titers
Interval 76.74 to 183.77
|
100.46 Titers
Interval 64.59 to 156.25
|
98.64 Titers
Interval 67.52 to 144.1
|
134.12 Titers
Interval 88.53 to 203.19
|
96.19 Titers
Interval 62.97 to 146.94
|
95.13 Titers
Interval 61.04 to 148.27
|
104.62 Titers
Interval 67.08 to 163.16
|
100.95 Titers
Interval 69.06 to 147.57
|
81.46 Titers
Interval 53.74 to 123.48
|
70.62 Titers
Interval 48.02 to 103.85
|
81.54 Titers
Interval 54.55 to 121.88
|
114.27 Titers
Interval 73.07 to 178.71
|
25.63 Titers
Interval 20.61 to 31.87
|
30.42 Titers
Interval 24.42 to 37.9
|
34.40 Titers
Interval 28.16 to 42.03
|
24.34 Titers
Interval 19.9 to 29.77
|
30.51 Titers
Interval 24.37 to 38.21
|
38.15 Titers
Interval 30.59 to 47.58
|
40.80 Titers
Interval 32.71 to 50.9
|
28.27 Titers
Interval 22.79 to 35.06
|
|
GMT of Antigen 1 Antibody Titer
Flu A2 Assay 1
|
12.27 Titers
Interval 8.51 to 17.7
|
40.48 Titers
Interval 27.31 to 60.01
|
20.58 Titers
Interval 13.87 to 30.55
|
28.67 Titers
Interval 20.36 to 40.36
|
20.24 Titers
Interval 13.92 to 29.44
|
39.35 Titers
Interval 26.84 to 57.71
|
23.54 Titers
Interval 15.85 to 34.97
|
34.09 Titers
Interval 22.84 to 50.89
|
31.34 Titers
Interval 22.27 to 44.12
|
29.18 Titers
Interval 20.02 to 42.53
|
29.37 Titers
Interval 20.79 to 41.5
|
25.72 Titers
Interval 17.89 to 36.97
|
12.73 Titers
Interval 8.5 to 19.06
|
40.76 Titers
Interval 33.62 to 49.42
|
46.04 Titers
Interval 37.98 to 55.82
|
45.33 Titers
Interval 38.02 to 54.04
|
30.65 Titers
Interval 25.64 to 36.64
|
58.66 Titers
Interval 48.07 to 71.59
|
66.14 Titers
Interval 54.44 to 80.35
|
65.11 Titers
Interval 53.72 to 78.92
|
44.85 Titers
Interval 37.05 to 54.29
|
|
GMT of Antigen 1 Antibody Titer
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
315.92 Titers
Interval 280.31 to 356.04
|
349.33 Titers
Interval 309.97 to 393.68
|
338.71 Titers
Interval 303.64 to 377.84
|
403.07 Titers
Interval 360.83 to 450.26
|
453.91 Titers
Interval 405.18 to 508.51
|
425.18 Titers
Interval 380.53 to 475.08
|
469.87 Titers
Interval 421.04 to 524.36
|
557.86 Titers
Interval 500.33 to 622.0
|
|
GMT of Antigen 1 Antibody Titer
Flu B2 Assay 1
|
290.27 Titers
Interval 222.31 to 379.0
|
517.33 Titers
Interval 388.49 to 688.89
|
444.01 Titers
Interval 333.25 to 591.58
|
451.08 Titers
Interval 351.73 to 578.49
|
498.91 Titers
Interval 379.85 to 655.28
|
449.90 Titers
Interval 340.69 to 594.12
|
413.03 Titers
Interval 309.73 to 550.79
|
666.47 Titers
Interval 498.26 to 891.47
|
489.90 Titers
Interval 381.71 to 628.75
|
448.11 Titers
Interval 340.62 to 589.53
|
461.80 Titers
Interval 358.83 to 594.32
|
428.52 Titers
Interval 329.05 to 558.08
|
791.84 Titers
Interval 590.49 to 1061.84
|
350.40 Titers
Interval 309.39 to 396.84
|
416.09 Titers
Interval 367.34 to 471.31
|
424.47 Titers
Interval 379.08 to 475.29
|
468.00 Titers
Interval 417.2 to 525.0
|
291.02 Titers
Interval 260.27 to 325.4
|
328.26 Titers
Interval 294.08 to 366.41
|
340.46 Titers
Interval 305.71 to 379.16
|
397.29 Titers
Interval 357.09 to 442.01
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 92Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=20 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=20 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=89 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=117 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=112 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=105 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=111 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=109 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Flu A1 Assay 1
|
6.95 Ratio
Interval 4.83 to 10.0
|
5.38 Ratio
Interval 3.82 to 7.56
|
3.96 Ratio
Interval 2.77 to 5.66
|
4.75 Ratio
Interval 3.36 to 6.72
|
5.05 Ratio
Interval 3.52 to 7.24
|
4.52 Ratio
Interval 3.16 to 6.44
|
4.53 Ratio
Interval 3.19 to 6.42
|
5.05 Ratio
Interval 3.53 to 7.23
|
5.30 Ratio
Interval 3.71 to 7.56
|
5.20 Ratio
Interval 3.63 to 7.45
|
3.88 Ratio
Interval 2.75 to 5.48
|
4.40 Ratio
Interval 3.1 to 6.25
|
4.88 Ratio
Interval 3.39 to 7.02
|
4.58 Ratio
Interval 3.62 to 5.8
|
5.44 Ratio
Interval 4.27 to 6.93
|
6.44 Ratio
Interval 5.2 to 7.98
|
4.13 Ratio
Interval 3.32 to 5.13
|
4.85 Ratio
Interval 3.84 to 6.12
|
6.05 Ratio
Interval 4.8 to 7.63
|
5.78 Ratio
Interval 4.59 to 7.28
|
4.00 Ratio
Interval 3.18 to 5.02
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Flu A2 Assay 1
|
1.00 Ratio
Interval 0.7 to 1.43
|
4.68 Ratio
Interval 3.35 to 6.54
|
2.54 Ratio
Interval 1.79 to 3.61
|
4.64 Ratio
Interval 3.3 to 6.52
|
2.49 Ratio
Interval 1.75 to 3.54
|
5.11 Ratio
Interval 3.61 to 7.25
|
3.35 Ratio
Interval 2.38 to 4.71
|
3.76 Ratio
Interval 2.64 to 5.34
|
3.67 Ratio
Interval 2.59 to 5.2
|
3.42 Ratio
Interval 2.4 to 4.88
|
4.73 Ratio
Interval 3.38 to 6.62
|
3.08 Ratio
Interval 2.18 to 4.34
|
1.54 Ratio
Interval 1.08 to 2.2
|
4.57 Ratio
Interval 3.74 to 5.59
|
5.10 Ratio
Interval 4.16 to 6.24
|
5.98 Ratio
Interval 4.99 to 7.16
|
2.82 Ratio
Interval 2.35 to 3.39
|
5.42 Ratio
Interval 4.43 to 6.63
|
5.66 Ratio
Interval 4.64 to 6.9
|
6.05 Ratio
Interval 4.97 to 7.36
|
3.77 Ratio
Interval 3.09 to 4.59
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.81 Ratio
Interval 1.58 to 2.07
|
1.87 Ratio
Interval 1.63 to 2.15
|
2.02 Ratio
Interval 1.78 to 2.28
|
2.30 Ratio
Interval 2.03 to 2.61
|
2.35 Ratio
Interval 2.09 to 2.65
|
2.28 Ratio
Interval 2.03 to 2.56
|
2.35 Ratio
Interval 2.09 to 2.64
|
3.20 Ratio
Interval 2.84 to 3.59
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Flu B1 Assay 2
|
1.27 Ratio
Interval 0.99 to 1.62
|
2.23 Ratio
Interval 1.77 to 2.8
|
2.05 Ratio
Interval 1.61 to 2.6
|
2.33 Ratio
Interval 1.85 to 2.94
|
2.52 Ratio
Interval 1.97 to 3.21
|
1.95 Ratio
Interval 1.54 to 2.48
|
1.91 Ratio
Interval 1.51 to 2.41
|
2.46 Ratio
Interval 1.93 to 3.13
|
2.30 Ratio
Interval 1.81 to 2.92
|
2.18 Ratio
Interval 1.71 to 2.78
|
2.50 Ratio
Interval 1.99 to 3.15
|
2.26 Ratio
Interval 1.78 to 2.88
|
3.47 Ratio
Interval 2.7 to 4.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 92
Flu B2 Assay 1
|
0.98 Ratio
Interval 0.76 to 1.27
|
2.25 Ratio
Interval 1.77 to 2.86
|
1.72 Ratio
Interval 1.33 to 2.21
|
2.09 Ratio
Interval 1.64 to 2.67
|
2.41 Ratio
Interval 1.86 to 3.1
|
2.08 Ratio
Interval 1.62 to 2.67
|
1.82 Ratio
Interval 1.42 to 2.33
|
2.44 Ratio
Interval 1.89 to 3.14
|
2.18 Ratio
Interval 1.69 to 2.8
|
1.98 Ratio
Interval 1.53 to 2.55
|
2.00 Ratio
Interval 1.57 to 2.55
|
1.98 Ratio
Interval 1.55 to 2.54
|
3.23 Ratio
Interval 2.5 to 4.18
|
1.63 Ratio
Interval 1.41 to 1.9
|
1.77 Ratio
Interval 1.52 to 2.06
|
1.94 Ratio
Interval 1.7 to 2.22
|
2.43 Ratio
Interval 2.12 to 2.79
|
2.05 Ratio
Interval 1.81 to 2.33
|
2.21 Ratio
Interval 1.95 to 2.5
|
2.33 Ratio
Interval 2.06 to 2.63
|
2.80 Ratio
Interval 2.47 to 3.16
|
SECONDARY outcome
Timeframe: From Day 1 (baseline) to Day 183Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=18 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=16 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=18 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=15 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=95 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=120 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=113 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=103 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=112 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=113 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Flu B1 Assay 2
|
1.50 Ratio
Interval 1.16 to 1.95
|
1.96 Ratio
Interval 1.48 to 2.59
|
1.91 Ratio
Interval 1.44 to 2.52
|
2.04 Ratio
Interval 1.6 to 2.6
|
1.75 Ratio
Interval 1.34 to 2.29
|
1.80 Ratio
Interval 1.37 to 2.36
|
1.99 Ratio
Interval 1.5 to 2.63
|
2.57 Ratio
Interval 1.94 to 3.42
|
2.05 Ratio
Interval 1.61 to 2.61
|
2.42 Ratio
Interval 1.85 to 3.16
|
2.02 Ratio
Interval 1.58 to 2.58
|
2.11 Ratio
Interval 1.62 to 2.75
|
2.59 Ratio
Interval 1.92 to 3.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Flu A1 Assay 1
|
3.55 Ratio
Interval 2.34 to 5.39
|
3.39 Ratio
Interval 2.19 to 5.25
|
2.87 Ratio
Interval 1.84 to 4.46
|
2.82 Ratio
Interval 1.93 to 4.11
|
3.83 Ratio
Interval 2.53 to 5.8
|
2.75 Ratio
Interval 1.8 to 4.2
|
2.72 Ratio
Interval 1.74 to 4.23
|
2.99 Ratio
Interval 1.92 to 4.66
|
2.88 Ratio
Interval 1.97 to 4.21
|
2.33 Ratio
Interval 1.53 to 3.53
|
2.02 Ratio
Interval 1.37 to 2.97
|
2.33 Ratio
Interval 1.56 to 3.48
|
3.26 Ratio
Interval 2.09 to 5.1
|
3.23 Ratio
Interval 2.6 to 4.02
|
3.84 Ratio
Interval 3.08 to 4.78
|
4.34 Ratio
Interval 3.55 to 5.3
|
3.07 Ratio
Interval 2.51 to 3.76
|
3.20 Ratio
Interval 2.55 to 4.01
|
4.00 Ratio
Interval 3.21 to 4.99
|
4.28 Ratio
Interval 3.43 to 5.34
|
2.96 Ratio
Interval 2.39 to 3.68
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Flu A2 Assay 1
|
1.06 Ratio
Interval 0.73 to 1.53
|
3.49 Ratio
Interval 2.35 to 5.17
|
1.77 Ratio
Interval 1.2 to 2.63
|
2.47 Ratio
Interval 1.76 to 3.48
|
1.74 Ratio
Interval 1.2 to 2.54
|
3.39 Ratio
Interval 2.31 to 4.97
|
2.03 Ratio
Interval 1.37 to 3.01
|
2.94 Ratio
Interval 1.97 to 4.39
|
2.70 Ratio
Interval 1.92 to 3.8
|
2.51 Ratio
Interval 1.73 to 3.67
|
2.53 Ratio
Interval 1.79 to 3.58
|
2.22 Ratio
Interval 1.54 to 3.19
|
1.10 Ratio
Interval 0.73 to 1.64
|
2.85 Ratio
Interval 2.35 to 3.46
|
3.22 Ratio
Interval 2.66 to 3.91
|
3.17 Ratio
Interval 2.66 to 3.78
|
2.15 Ratio
Interval 1.79 to 2.57
|
2.99 Ratio
Interval 2.45 to 3.65
|
3.37 Ratio
Interval 2.78 to 4.1
|
3.32 Ratio
Interval 2.74 to 4.03
|
2.29 Ratio
Interval 1.89 to 2.77
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.58 Ratio
Interval 1.41 to 1.79
|
1.75 Ratio
Interval 1.56 to 1.97
|
1.70 Ratio
Interval 1.52 to 1.9
|
2.02 Ratio
Interval 1.81 to 2.26
|
2.02 Ratio
Interval 1.81 to 2.27
|
1.89 Ratio
Interval 1.7 to 2.12
|
2.09 Ratio
Interval 1.88 to 2.34
|
2.49 Ratio
Interval 2.23 to 2.77
|
|
GMI of Antigen 1 Antibody Titer From Day 1 to Day 183
Flu B2 Assay 1
|
1.31 Ratio
Interval 1.0 to 1.71
|
2.34 Ratio
Interval 1.75 to 3.11
|
2.01 Ratio
Interval 1.51 to 2.67
|
2.04 Ratio
Interval 1.59 to 2.61
|
2.25 Ratio
Interval 1.72 to 2.96
|
2.03 Ratio
Interval 1.54 to 2.68
|
1.87 Ratio
Interval 1.4 to 2.49
|
3.01 Ratio
Interval 2.25 to 4.03
|
2.21 Ratio
Interval 1.72 to 2.84
|
2.02 Ratio
Interval 1.54 to 2.66
|
2.09 Ratio
Interval 1.62 to 2.68
|
1.94 Ratio
Interval 1.49 to 2.52
|
3.58 Ratio
Interval 2.67 to 4.8
|
1.16 Ratio
Interval 1.03 to 1.32
|
1.38 Ratio
Interval 1.22 to 1.57
|
1.41 Ratio
Interval 1.26 to 1.58
|
1.56 Ratio
Interval 1.39 to 1.74
|
1.34 Ratio
Interval 1.19 to 1.49
|
1.51 Ratio
Interval 1.35 to 1.68
|
1.56 Ratio
Interval 1.4 to 1.74
|
1.82 Ratio
Interval 1.64 to 2.03
|
SECONDARY outcome
Timeframe: At Day 183Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Assay 1= with egg propagated Influenza virus and Assay 2= with cell propagated Influenza virus.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=18 Participants
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=16 Participants
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=15 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=17 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=18 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=15 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=95 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=120 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=113 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=103 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=112 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=113 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A1 Assay 1
|
94.1 Percentage of participants
Interval 71.3 to 99.9
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
100 Percentage of participants
Interval 80.5 to 100.0
|
81.3 Percentage of participants
Interval 54.4 to 96.0
|
93.3 Percentage of participants
Interval 68.1 to 99.8
|
80.0 Percentage of participants
Interval 51.9 to 95.7
|
95.0 Percentage of participants
Interval 75.1 to 99.9
|
82.4 Percentage of participants
Interval 56.6 to 96.2
|
65.0 Percentage of participants
Interval 40.8 to 84.6
|
77.8 Percentage of participants
Interval 52.4 to 93.6
|
86.7 Percentage of participants
Interval 59.5 to 98.3
|
44.2 Percentage of participants
Interval 34.0 to 54.8
|
47.4 Percentage of participants
Interval 37.0 to 57.9
|
47.5 Percentage of participants
Interval 38.2 to 56.9
|
37.2 Percentage of participants
Interval 28.3 to 46.8
|
39.8 Percentage of participants
Interval 30.3 to 49.9
|
48.1 Percentage of participants
Interval 38.4 to 58.0
|
51.8 Percentage of participants
Interval 42.1 to 61.4
|
40.7 Percentage of participants
Interval 31.6 to 50.4
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu A2 Assay 1
|
22.2 Percentage of participants
Interval 6.4 to 47.6
|
66.7 Percentage of participants
Interval 38.4 to 88.2
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
60.0 Percentage of participants
Interval 36.1 to 80.9
|
47.1 Percentage of participants
Interval 23.0 to 72.2
|
56.3 Percentage of participants
Interval 29.9 to 80.2
|
46.7 Percentage of participants
Interval 21.3 to 73.4
|
73.3 Percentage of participants
Interval 44.9 to 92.2
|
50.0 Percentage of participants
Interval 27.2 to 72.8
|
52.9 Percentage of participants
Interval 27.8 to 77.0
|
45.0 Percentage of participants
Interval 23.1 to 68.5
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
33.3 Percentage of participants
Interval 11.8 to 61.6
|
59.4 Percentage of participants
Interval 48.9 to 69.3
|
63.2 Percentage of participants
Interval 52.6 to 72.8
|
64.2 Percentage of participants
Interval 54.9 to 72.7
|
54.9 Percentage of participants
Interval 45.2 to 64.2
|
67.0 Percentage of participants
Interval 57.0 to 75.9
|
66.4 Percentage of participants
Interval 56.7 to 75.1
|
70.5 Percentage of participants
Interval 61.2 to 78.8
|
58.4 Percentage of participants
Interval 48.8 to 67.6
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.5 to 100.0
|
100 Percentage of participants
Interval 96.7 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B1 Assay 2
|
88.9 Percentage of participants
Interval 65.3 to 98.6
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 79.4 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 81.5 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Antigen 1 Antibody SPR
Flu B2 Assay 1
|
100 Percentage of participants
Interval 81.5 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 79.4 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 80.5 to 100.0
|
100 Percentage of participants
Interval 83.2 to 100.0
|
100 Percentage of participants
Interval 81.5 to 100.0
|
100 Percentage of participants
Interval 78.2 to 100.0
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 96.2 to 100.0
|
100 Percentage of participants
Interval 97.0 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
99.0 Percentage of participants
Interval 94.7 to 100.0
|
100 Percentage of participants
Interval 96.7 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
100 Percentage of participants
Interval 96.8 to 100.0
|
SECONDARY outcome
Timeframe: At Day 92 and Day 183Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=20 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=95 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=120 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=113 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=105 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=112 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=113 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Antigen 2 Antibody Titer
Flu A1, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
3413.56 Titers
Interval 2608.88 to 4466.45
|
3012.57 Titers
Interval 2280.43 to 3979.78
|
2965.07 Titers
Interval 2254.8 to 3899.08
|
3738.95 Titers
Interval 2826.14 to 4946.58
|
3441.57 Titers
Interval 2638.9 to 4488.39
|
4274.50 Titers
Interval 3261.91 to 5601.42
|
1169.80 Titers
Interval 877.58 to 1559.32
|
571.40 Titers
Interval 478.17 to 682.8
|
722.85 Titers
Interval 602.29 to 867.53
|
734.36 Titers
Interval 624.97 to 862.91
|
128.40 Titers
Interval 108.98 to 151.28
|
684.46 Titers
Interval 583.38 to 803.06
|
674.07 Titers
Interval 575.98 to 788.85
|
791.40 Titers
Interval 677.27 to 924.77
|
172.46 Titers
Interval 147.38 to 201.79
|
|
GMT of Antigen 2 Antibody Titer
Flu A1, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
3564.38 Titers
Interval 2560.66 to 4961.53
|
2635.37 Titers
Interval 1880.45 to 3693.34
|
2682.13 Titers
Interval 2018.21 to 3564.44
|
3489.51 Titers
Interval 2546.78 to 4781.21
|
3472.42 Titers
Interval 2596.95 to 4643.03
|
4239.44 Titers
Interval 3136.1 to 5730.94
|
1048.36 Titers
Interval 741.3 to 1482.62
|
444.85 Titers
Interval 370.47 to 534.16
|
534.28 Titers
Interval 444.54 to 642.14
|
545.14 Titers
Interval 461.18 to 644.39
|
132.78 Titers
Interval 112.08 to 157.3
|
532.03 Titers
Interval 446.15 to 634.43
|
470.78 Titers
Interval 396.55 to 558.89
|
612.30 Titers
Interval 516.57 to 725.78
|
166.23 Titers
Interval 140.42 to 196.79
|
|
GMT of Antigen 2 Antibody Titer
Flu A2, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
637.45 Titers
Interval 519.98 to 781.47
|
844.82 Titers
Interval 683.69 to 1043.93
|
636.20 Titers
Interval 517.35 to 782.37
|
696.15 Titers
Interval 561.66 to 862.84
|
784.67 Titers
Interval 641.72 to 959.47
|
844.05 Titers
Interval 685.93 to 1038.61
|
411.14 Titers
Interval 330.13 to 512.03
|
827.90 Titers
Interval 734.62 to 933.03
|
875.59 Titers
Interval 775.24 to 988.93
|
1005.14 Titers
Interval 901.57 to 1120.61
|
416.04 Titers
Interval 372.71 to 464.4
|
1202.72 Titers
Interval 1070.36 to 1351.46
|
1275.88 Titers
Interval 1137.26 to 1431.4
|
1394.04 Titers
Interval 1244.06 to 1562.11
|
566.45 Titers
Interval 505.0 to 635.39
|
|
GMT of Antigen 2 Antibody Titer
Flu A2, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
482.94 Titers
Interval 365.04 to 638.93
|
691.16 Titers
Interval 517.52 to 923.07
|
538.10 Titers
Interval 422.45 to 685.42
|
593.16 Titers
Interval 451.41 to 779.42
|
653.49 Titers
Interval 510.58 to 836.39
|
661.58 Titers
Interval 510.14 to 857.99
|
302.98 Titers
Interval 225.2 to 407.64
|
492.09 Titers
Interval 440.03 to 550.32
|
551.37 Titers
Interval 492.98 to 616.68
|
585.21 Titers
Interval 528.14 to 648.44
|
271.70 Titers
Interval 244.99 to 301.31
|
727.45 Titers
Interval 644.79 to 820.72
|
700.38 Titers
Interval 622.6 to 787.88
|
816.15 Titers
Interval 726.38 to 917.02
|
397.88 Titers
Interval 354.41 to 446.67
|
|
GMT of Antigen 2 Antibody Titer
Flu B1, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
365.32 Titers
Interval 275.53 to 484.38
|
576.79 Titers
Interval 431.04 to 771.82
|
401.61 Titers
Interval 301.39 to 535.16
|
483.67 Titers
Interval 361.55 to 647.04
|
385.93 Titers
Interval 292.19 to 509.74
|
438.90 Titers
Interval 329.69 to 584.3
|
261.90 Titers
Interval 193.56 to 354.37
|
409.51 Titers
Interval 361.2 to 464.28
|
501.61 Titers
Interval 441.78 to 569.55
|
512.92 Titers
Interval 458.15 to 574.23
|
267.02 Titers
Interval 237.93 to 299.66
|
538.58 Titers
Interval 470.6 to 616.38
|
574.01 Titers
Interval 502.8 to 655.3
|
611.15 Titers
Interval 535.89 to 696.97
|
355.51 Titers
Interval 311.44 to 405.82
|
|
GMT of Antigen 2 Antibody Titer
Flu B1, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
384.20 Titers
Interval 276.74 to 533.38
|
716.17 Titers
Interval 511.59 to 1002.56
|
439.50 Titers
Interval 330.94 to 583.68
|
586.65 Titers
Interval 429.01 to 802.23
|
419.67 Titers
Interval 314.35 to 560.29
|
484.54 Titers
Interval 357.96 to 655.88
|
326.16 Titers
Interval 230.47 to 461.58
|
307.31 Titers
Interval 272.34 to 346.78
|
371.76 Titers
Interval 329.66 to 419.23
|
372.01 Titers
Interval 333.35 to 415.16
|
221.57 Titers
Interval 198.2 to 247.69
|
375.13 Titers
Interval 332.23 to 423.57
|
388.81 Titers
Interval 345.37 to 437.72
|
449.14 Titers
Interval 399.38 to 505.1
|
288.98 Titers
Interval 257.24 to 324.65
|
|
GMT of Antigen 2 Antibody Titer
Flu B2, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
1815.84 Titers
Interval 1413.39 to 2332.89
|
2569.92 Titers
Interval 1982.5 to 3331.39
|
1866.83 Titers
Interval 1445.98 to 2410.18
|
2361.25 Titers
Interval 1822.4 to 3059.42
|
1762.98 Titers
Interval 1376.82 to 2257.45
|
1909.41 Titers
Interval 1483.64 to 2457.36
|
1298.81 Titers
Interval 992.67 to 1699.36
|
1966.97 Titers
Interval 1784.99 to 2167.49
|
2217.80 Titers
Interval 2008.88 to 2448.46
|
2214.84 Titers
Interval 2028.65 to 2418.13
|
1080.66 Titers
Interval 987.93 to 1182.1
|
2649.22 Titers
Interval 2383.01 to 2945.16
|
2803.91 Titers
Interval 2525.91 to 3112.5
|
3061.97 Titers
Interval 2760.37 to 3396.52
|
1725.34 Titers
Interval 1554.32 to 1915.18
|
|
GMT of Antigen 2 Antibody Titer
Flu B2, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
1633.79 Titers
Interval 1240.95 to 2150.98
|
2310.02 Titers
Interval 1742.83 to 3061.81
|
1613.52 Titers
Interval 1271.8 to 2047.06
|
2262.11 Titers
Interval 1739.52 to 2941.69
|
1513.91 Titers
Interval 1188.47 to 1928.46
|
1744.56 Titers
Interval 1356.31 to 2243.96
|
1187.10 Titers
Interval 888.3 to 1586.4
|
1494.07 Titers
Interval 1340.65 to 1665.05
|
1722.00 Titers
Interval 1544.83 to 1919.48
|
1688.96 Titers
Interval 1529.84 to 1864.62
|
940.94 Titers
Interval 850.96 to 1040.42
|
1923.64 Titers
Interval 1731.04 to 2137.67
|
2036.73 Titers
Interval 1837.19 to 2257.94
|
2288.21 Titers
Interval 2065.66 to 2534.74
|
1464.14 Titers
Interval 1323.11 to 1620.21
|
SECONDARY outcome
Timeframe: From Day 1 to Day 92 and Day 1 to Day 183Population: The analysis was performed on the PPS. Only participants with data available for the specified analysis at the specified timepoints were included.
Outcome measures
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=20 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=22 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 Participants
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=20 Participants
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=96 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=95 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=120 Participants
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=113 Participants
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=105 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=110 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=112 Participants
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=113 Participants
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMI of Antigen 2 Antibody Titer
Flu B2, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
3.05 Ratio
Interval 2.31 to 4.01
|
4.31 Ratio
Interval 3.25 to 5.71
|
3.01 Ratio
Interval 2.37 to 3.82
|
4.22 Ratio
Interval 3.24 to 5.49
|
2.82 Ratio
Interval 2.22 to 3.6
|
3.25 Ratio
Interval 2.53 to 4.18
|
2.21 Ratio
Interval 1.66 to 2.96
|
2.12 Ratio
Interval 1.9 to 2.36
|
2.44 Ratio
Interval 2.19 to 2.72
|
2.39 Ratio
Interval 2.17 to 2.64
|
1.33 Ratio
Interval 1.21 to 1.47
|
2.03 Ratio
Interval 1.82 to 2.25
|
2.15 Ratio
Interval 1.94 to 2.38
|
2.41 Ratio
Interval 2.18 to 2.67
|
1.54 Ratio
Interval 1.39 to 1.71
|
|
GMI of Antigen 2 Antibody Titer
Flu A1, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
4.24 Ratio
Interval 3.24 to 5.55
|
3.74 Ratio
Interval 2.83 to 4.94
|
3.68 Ratio
Interval 2.8 to 4.84
|
4.64 Ratio
Interval 3.51 to 6.14
|
4.27 Ratio
Interval 3.28 to 5.57
|
5.31 Ratio
Interval 4.05 to 6.95
|
1.45 Ratio
Interval 1.09 to 1.94
|
4.83 Ratio
Interval 4.04 to 5.77
|
6.11 Ratio
Interval 5.09 to 7.33
|
6.20 Ratio
Interval 5.28 to 7.29
|
1.08 Ratio
Interval 0.92 to 1.28
|
4.75 Ratio
Interval 4.05 to 5.57
|
4.67 Ratio
Interval 3.99 to 5.47
|
5.49 Ratio
Interval 4.7 to 6.41
|
1.20 Ratio
Interval 1.02 to 1.4
|
|
GMI of Antigen 2 Antibody Titer
Flu A1, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
4.19 Ratio
Interval 3.01 to 5.83
|
3.10 Ratio
Interval 2.21 to 4.34
|
3.15 Ratio
Interval 2.37 to 4.19
|
4.10 Ratio
Interval 2.99 to 5.62
|
4.08 Ratio
Interval 3.05 to 5.46
|
4.98 Ratio
Interval 3.69 to 6.74
|
1.23 Ratio
Interval 0.87 to 1.74
|
3.77 Ratio
Interval 3.14 to 4.53
|
4.53 Ratio
Interval 3.77 to 5.45
|
4.62 Ratio
Interval 3.91 to 5.47
|
1.13 Ratio
Interval 0.95 to 1.33
|
3.73 Ratio
Interval 3.13 to 4.45
|
3.30 Ratio
Interval 2.78 to 3.92
|
4.30 Ratio
Interval 3.62 to 5.09
|
1.17 Ratio
Interval 0.99 to 1.38
|
|
GMI of Antigen 2 Antibody Titer
Flu A2, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
3.28 Ratio
Interval 2.67 to 4.02
|
4.35 Ratio
Interval 3.52 to 5.37
|
3.27 Ratio
Interval 2.66 to 4.02
|
3.58 Ratio
Interval 2.89 to 4.44
|
4.04 Ratio
Interval 3.3 to 4.93
|
4.34 Ratio
Interval 3.53 to 5.34
|
2.11 Ratio
Interval 1.7 to 2.63
|
3.41 Ratio
Interval 3.03 to 3.84
|
3.61 Ratio
Interval 3.19 to 4.07
|
4.14 Ratio
Interval 3.71 to 4.62
|
1.71 Ratio
Interval 1.54 to 1.91
|
3.62 Ratio
Interval 3.22 to 4.07
|
3.84 Ratio
Interval 3.42 to 4.31
|
4.20 Ratio
Interval 3.75 to 4.7
|
1.71 Ratio
Interval 1.52 to 1.91
|
|
GMI of Antigen 2 Antibody Titer
Flu A2, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
2.54 Ratio
Interval 1.92 to 3.36
|
3.63 Ratio
Interval 2.72 to 4.85
|
2.83 Ratio
Interval 2.22 to 3.6
|
3.12 Ratio
Interval 2.37 to 4.09
|
3.43 Ratio
Interval 2.68 to 4.39
|
3.48 Ratio
Interval 2.68 to 4.51
|
1.59 Ratio
Interval 1.18 to 2.14
|
2.02 Ratio
Interval 1.81 to 2.26
|
2.26 Ratio
Interval 2.03 to 2.53
|
2.40 Ratio
Interval 2.17 to 2.66
|
1.12 Ratio
Interval 1.01 to 1.24
|
2.18 Ratio
Interval 1.94 to 2.46
|
2.10 Ratio
Interval 1.87 to 2.37
|
2.45 Ratio
Interval 2.18 to 2.75
|
1.19 Ratio
Interval 1.06 to 1.34
|
|
GMI of Antigen 2 Antibody Titer
Flu B1, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
1.23 Ratio
Interval 0.93 to 1.63
|
1.94 Ratio
Interval 1.45 to 2.59
|
1.35 Ratio
Interval 1.01 to 1.8
|
1.63 Ratio
Interval 1.22 to 2.18
|
1.30 Ratio
Interval 0.98 to 1.71
|
1.48 Ratio
Interval 1.11 to 1.96
|
0.88 Ratio
Interval 0.65 to 1.19
|
2.43 Ratio
Interval 2.15 to 2.76
|
2.98 Ratio
Interval 2.63 to 3.38
|
3.05 Ratio
Interval 2.72 to 3.41
|
1.59 Ratio
Interval 1.41 to 1.78
|
2.29 Ratio
Interval 2.0 to 2.62
|
2.44 Ratio
Interval 2.14 to 2.78
|
2.60 Ratio
Interval 2.28 to 2.96
|
1.51 Ratio
Interval 1.32 to 1.72
|
|
GMI of Antigen 2 Antibody Titer
Flu B1, Post-dosing at Day 183
|
—
|
—
|
—
|
—
|
—
|
—
|
1.27 Ratio
Interval 0.91 to 1.76
|
2.36 Ratio
Interval 1.69 to 3.31
|
1.45 Ratio
Interval 1.09 to 1.93
|
1.94 Ratio
Interval 1.42 to 2.65
|
1.39 Ratio
Interval 1.04 to 1.85
|
1.60 Ratio
Interval 1.18 to 2.16
|
1.08 Ratio
Interval 0.76 to 1.52
|
1.82 Ratio
Interval 1.61 to 2.05
|
2.20 Ratio
Interval 1.95 to 2.48
|
2.20 Ratio
Interval 1.97 to 2.46
|
1.31 Ratio
Interval 1.17 to 1.47
|
1.57 Ratio
Interval 1.39 to 1.78
|
1.63 Ratio
Interval 1.45 to 1.84
|
1.88 Ratio
Interval 1.68 to 2.12
|
1.21 Ratio
Interval 1.08 to 1.36
|
|
GMI of Antigen 2 Antibody Titer
Flu B2, Post-dosing at Day 92
|
—
|
—
|
—
|
—
|
—
|
—
|
3.46 Ratio
Interval 2.7 to 4.45
|
4.90 Ratio
Interval 3.78 to 6.35
|
3.56 Ratio
Interval 2.76 to 4.6
|
4.50 Ratio
Interval 3.48 to 5.83
|
3.36 Ratio
Interval 2.63 to 4.31
|
3.64 Ratio
Interval 2.83 to 4.69
|
2.48 Ratio
Interval 1.89 to 3.24
|
2.80 Ratio
Interval 2.54 to 3.08
|
3.15 Ratio
Interval 2.86 to 3.48
|
3.15 Ratio
Interval 2.88 to 3.44
|
1.54 Ratio
Interval 1.4 to 1.68
|
2.84 Ratio
Interval 2.55 to 3.15
|
3.00 Ratio
Interval 2.7 to 3.33
|
3.28 Ratio
Interval 2.95 to 3.63
|
1.85 Ratio
Interval 1.66 to 2.05
|
Adverse Events
Flu mRNA_Ph1_1 Younger Adults (YA) Group
Flu mRNA_Ph1_2 YA Group
Flu mRNA_Ph1_3 YA Group
Flu mRNA_Ph1_4 YA Group
Flu mRNA_Ph1_5 YA Group
Flu mRNA_Ph1_6 YA Group
Flu mRNA_Ph1_7 YA Group
Flu mRNA_Ph1_8 YA Group
Flu mRNA_Ph1_9 YA Group
Flu mRNA_Ph1_10 YA Group
Flu mRNA_Ph1_11 YA Group
Flu mRNA_Ph1_12 YA Group
Control Ph1_YA Group
Flu mRNA_Ph2_1_YA Group
Flu mRNA_Ph2_2_YA Group
Flu mRNA_Ph2_3_YA Group
Control_Ph2_YA Group
Flu mRNA_Ph2_1_Older Adults (OA) Group
Flu mRNA_Ph2_2_OA Group
Flu mRNA_Ph2_3_OA Group
Control_Ph2_OA Group
Serious adverse events
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 participants at risk
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 participants at risk
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 participants at risk
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 participants at risk
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Erysipelas
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Liver abscess
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Meningitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to kidney
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
Other adverse events
| Measure |
Flu mRNA_Ph1_1 Younger Adults (YA) Group
n=21 participants at risk
YA Participants received a single dose of Flu mRNA study intervention F2C22C/DL001Z (GSKVx000000039714) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_2 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22A/DL001Z (GSKVx000000040038) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_3 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22B/DL001Z (GSKVx000000040668) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_4 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22C/DL001Z (GSKVx000000040671) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_5 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22D/DL001Z (GSKVx000000040674) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_6 YA Group
n=25 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2B22E/DL001Z (GSKVx000000040677) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_7 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22A/DL001Z (GSKVx000000040641) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_8 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22B/DL001Z (GSKVx000000040644) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_9 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA (GSK4382276A) study intervention F2F22C/DL001Z (GSKVx000000040647) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_10 YA Group
n=22 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22D/DL001Z (GSKVx000000040650) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_11 YA Group
n=23 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22E/DL001Z (GSKVx000000040996) administered in Phase 1, at Day 1.
|
Flu mRNA_Ph1_12 YA Group
n=21 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F22F/DL001Z (GSKVx000000040999) administered in Phase 1, at Day 1.
|
Control Ph1_YA Group
n=23 participants at risk
YA participants received a single dose of Control 1 administered in Phase 1, at Day 1.
|
Flu mRNA_Ph2_1_YA Group
n=115 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23D/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_YA Group
n=108 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1
|
Flu mRNA_Ph2_3_YA Group
n=137 participants at risk
YA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_YA Group
n=120 participants at risk
YA participants received single dose of Control 2 vaccine administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_1_Older Adults (OA) Group
n=119 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23A/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_2_OA Group
n=122 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23B/DL001Z-NH administered in Phase 2, at Day 1.
|
Flu mRNA_Ph2_3_OA Group
n=125 participants at risk
OA participants received a single dose of Flu mRNA study intervention F2F23C/DL001Z-NH administered in Phase 2, at Day 1.
|
Control_Ph2_OA Group
n=117 participants at risk
OA participants received a single dose of Control 3 vaccine administered in Phase 2, at Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Fatigue
|
47.6%
10/21 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.9%
17/23 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
78.3%
18/23 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
77.3%
17/22 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.0%
18/25 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
69.6%
16/23 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.9%
17/23 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.7%
16/22 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
78.3%
18/23 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
81.0%
17/21 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
50.4%
58/115 • Number of events 58 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
64.8%
70/108 • Number of events 70 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
75.2%
103/137 • Number of events 104 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.8%
49/120 • Number of events 49 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
37.0%
44/119 • Number of events 44 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
41.8%
51/122 • Number of events 51 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.0%
65/125 • Number of events 66 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.2%
26/117 • Number of events 26 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
28.6%
6/21 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.5%
10/22 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
34.8%
8/23 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
43.5%
10/23 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.5%
10/22 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
56.0%
14/25 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.7%
5/23 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.9%
9/22 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
34.8%
8/23 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.5%
10/22 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
34.8%
8/23 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.4%
11/21 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
24.3%
28/115 • Number of events 28 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
38.0%
41/108 • Number of events 41 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
38.7%
53/137 • Number of events 54 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
12.5%
15/120 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
16.8%
20/119 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
15.6%
19/122 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.2%
14/125 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.5%
10/117 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
4/108 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.5%
2/137 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/117 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Blepharitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Lens disorder
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Eye disorders
Retinal detachment
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.1%
2/22 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
4/137 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/125 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chest discomfort
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.6%
3/22 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.6%
3/22 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.1%
2/22 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.5%
2/21 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.6%
6/108 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.1%
7/137 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site erythema
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.1%
2/22 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.6%
3/22 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
16.0%
4/25 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.6%
3/22 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.0%
3/23 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
14.3%
3/21 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.6%
3/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.6%
5/108 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.8%
8/137 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.0%
6/119 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.7%
7/122 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.2%
9/125 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.4%
4/117 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site pain
|
71.4%
15/21 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
91.3%
21/23 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
87.0%
20/23 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
88.0%
22/25 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
78.3%
18/23 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.4%
19/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
91.3%
21/23 • Number of events 21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
85.7%
18/21 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
56.5%
13/23 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
71.3%
82/115 • Number of events 82 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
79.6%
86/108 • Number of events 86 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
86.1%
118/137 • Number of events 118 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
44.2%
53/120 • Number of events 53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.9%
63/119 • Number of events 63 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.5%
64/122 • Number of events 64 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
62.4%
78/125 • Number of events 78 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.0%
41/117 • Number of events 41 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Administration site swelling
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
2/25 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.1%
2/22 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.0%
3/23 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
13.0%
3/23 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
14.3%
3/21 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.6%
3/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.5%
7/108 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.1%
7/137 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.0%
6/119 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.1%
5/122 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.4%
8/125 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.1%
6/117 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Asthenia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/115 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.8%
3/108 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.8%
8/137 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chills
|
19.0%
4/21 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.5%
12/22 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
47.8%
11/23 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
60.9%
14/23 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.5%
10/22 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
36.0%
9/25 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
68.2%
15/22 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
52.2%
12/23 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.5%
12/22 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
87.0%
20/23 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
61.9%
13/21 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.1%
30/115 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
36.1%
39/108 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
53.3%
73/137 • Number of events 73 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
15.0%
18/120 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
15.1%
18/119 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
15.6%
19/122 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
29.6%
37/125 • Number of events 38 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
6.0%
7/117 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Chest pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Feeling hot
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
5/115 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.6%
5/137 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Hangover
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
2/108 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
5/120 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.4%
3/125 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site bruising
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site erythema
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site induration
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site irritation
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site movement impairment
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site pruritus
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
14.3%
3/21 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.2%
4/125 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site rash
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site swelling
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Injection site warmth
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Malaise
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.5%
2/137 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Mass
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Pyrexia
|
9.5%
2/21 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.1%
2/22 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.1%
6/23 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
43.5%
10/23 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
18.2%
4/22 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
34.8%
8/23 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.7%
5/22 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
30.4%
7/23 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.7%
5/22 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
28.6%
6/21 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
5/115 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.4%
8/108 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
18.2%
25/137 • Number of events 25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.1%
5/122 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
11.2%
14/125 • Number of events 14 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/117 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Vaccination site pruritus
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
COVID-19
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
2/108 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.5%
2/137 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.8%
7/120 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.3%
4/122 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Cystitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Gonorrhoea
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Influenza
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/119 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Mycoplasma genitalium infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
5/115 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.4%
8/108 • Number of events 8 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.1%
7/137 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.2%
5/120 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.4%
4/119 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.5%
3/122 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/125 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.4%
4/117 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/125 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Otitis media
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Tooth infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.6%
3/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.9%
4/137 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/119 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/122 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.8%
3/108 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
Troponin increased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
3/21 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.5%
12/22 • Number of events 12 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
43.5%
10/23 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
11/22 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.0%
10/25 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
50.0%
11/22 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
47.8%
11/23 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
31.8%
7/22 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
47.6%
10/21 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
27.0%
31/115 • Number of events 32 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.2%
38/108 • Number of events 38 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
35.0%
48/137 • Number of events 48 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
9.2%
11/120 • Number of events 11 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
12.6%
15/119 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
22.1%
27/122 • Number of events 30 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
26.4%
33/125 • Number of events 33 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
7.7%
9/117 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/115 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
2/108 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.6%
5/137 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/125 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
47.6%
10/21 • Number of events 10 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
95.5%
21/22 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
78.3%
18/23 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
68.2%
15/22 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
76.0%
19/25 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 15 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.7%
16/22 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.9%
17/23 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
81.8%
18/22 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
91.3%
21/23 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
85.7%
18/21 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
39.1%
9/23 • Number of events 9 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
49.6%
57/115 • Number of events 58 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
64.8%
70/108 • Number of events 71 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.3%
99/137 • Number of events 101 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
29.2%
35/120 • Number of events 36 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
30.3%
36/119 • Number of events 36 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
32.8%
40/122 • Number of events 40 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
45.6%
57/125 • Number of events 58 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
16.2%
19/117 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.0%
2/25 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.5%
2/137 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.5%
2/137 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/117 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Ageusia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Dizziness
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.6%
5/108 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.1%
7/137 • Number of events 7 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/125 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.6%
3/117 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Headache
|
52.4%
11/21 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
77.3%
17/22 • Number of events 19 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.9%
17/23 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.7%
16/22 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
68.0%
17/25 • Number of events 22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
65.2%
15/23 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
77.3%
17/22 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
60.9%
14/23 • Number of events 16 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
72.7%
16/22 • Number of events 18 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.9%
17/23 • Number of events 17 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
61.9%
13/21 • Number of events 13 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
21.7%
5/23 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
48.7%
56/115 • Number of events 59 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
54.6%
59/108 • Number of events 63 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
73.7%
101/137 • Number of events 109 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
31.7%
38/120 • Number of events 42 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
32.8%
39/119 • Number of events 40 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
30.3%
37/122 • Number of events 39 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
40.8%
51/125 • Number of events 53 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
17.1%
20/117 • Number of events 20 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Migraine
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Irritability
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Psychiatric disorders
Poor quality sleep
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
12.0%
3/25 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.2%
3/137 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
5.0%
6/120 • Number of events 6 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/122 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
8.7%
2/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.6%
5/137 • Number of events 5 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.6%
3/115 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
3.7%
4/108 • Number of events 4 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.6%
2/122 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.84%
1/119 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.5%
1/22 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
2.2%
3/137 • Number of events 3 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
1.9%
2/108 • Number of events 2 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.0%
1/25 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Sensitive skin
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.80%
1/125 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.82%
1/122 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.8%
1/21 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.87%
1/115 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Flushing
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hot flush
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.93%
1/108 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.73%
1/137 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/117 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/25 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
4.3%
1/23 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/22 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/21 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/23 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/115 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/108 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/137 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/120 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/119 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/122 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.00%
0/125 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
0.85%
1/117 • Number of events 1 • Solicited AEs were collected from Day 1 to Day 7; Unsolicited AEs: Day 1 to day 28; All-cause mortality, SAEs, AESIs, and MAEs: from first vaccination (Day 1) up to study end (Day 183)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER