Trial Outcomes & Findings for A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults (NCT NCT05827926)
NCT ID: NCT05827926
Last Updated: 2025-12-23
Results Overview
Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1758 participants
Primary outcome timeframe
Up to 7 days after study injection
Results posted on
2025-12-23
Participant Flow
Participant milestones
| Measure |
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A13: Influenza Vaccine 2
Participants received a single IM injection of Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Received Study Injection
|
41
|
41
|
40
|
40
|
40
|
42
|
54
|
53
|
54
|
51
|
54
|
52
|
51
|
33
|
54
|
54
|
33
|
53
|
52
|
55
|
55
|
53
|
55
|
55
|
56
|
37
|
55
|
55
|
38
|
54
|
40
|
39
|
40
|
42
|
40
|
40
|
42
|
|
Overall Study
STARTED
|
42
|
41
|
40
|
40
|
40
|
42
|
54
|
53
|
54
|
53
|
54
|
52
|
52
|
33
|
54
|
54
|
33
|
53
|
52
|
56
|
56
|
56
|
55
|
56
|
56
|
37
|
55
|
56
|
38
|
56
|
41
|
40
|
40
|
42
|
40
|
40
|
42
|
|
Overall Study
Safety Set
|
41
|
41
|
40
|
40
|
40
|
42
|
54
|
53
|
54
|
51
|
54
|
52
|
51
|
33
|
55
|
53
|
33
|
53
|
52
|
55
|
55
|
53
|
55
|
56
|
55
|
37
|
56
|
54
|
38
|
54
|
40
|
39
|
40
|
42
|
40
|
40
|
42
|
|
Overall Study
Solicited Safety Set
|
41
|
41
|
40
|
40
|
40
|
42
|
54
|
53
|
54
|
51
|
54
|
52
|
51
|
33
|
55
|
53
|
33
|
53
|
52
|
55
|
55
|
53
|
55
|
56
|
55
|
37
|
56
|
54
|
38
|
53
|
40
|
39
|
40
|
42
|
40
|
40
|
42
|
|
Overall Study
Per Protocol Set
|
40
|
39
|
40
|
38
|
33
|
42
|
51
|
50
|
50
|
45
|
51
|
49
|
50
|
30
|
53
|
51
|
31
|
50
|
50
|
48
|
52
|
50
|
53
|
51
|
53
|
36
|
50
|
52
|
38
|
51
|
38
|
38
|
37
|
40
|
38
|
39
|
42
|
|
Overall Study
Full Analysis Set (FAS)
|
41
|
41
|
40
|
40
|
40
|
42
|
54
|
53
|
54
|
51
|
54
|
52
|
51
|
33
|
54
|
54
|
33
|
53
|
52
|
55
|
55
|
53
|
55
|
55
|
56
|
37
|
55
|
55
|
38
|
54
|
40
|
39
|
40
|
42
|
40
|
40
|
42
|
|
Overall Study
COMPLETED
|
39
|
38
|
38
|
39
|
37
|
37
|
52
|
53
|
53
|
51
|
54
|
51
|
51
|
33
|
54
|
54
|
33
|
53
|
50
|
53
|
55
|
52
|
52
|
55
|
55
|
37
|
53
|
53
|
36
|
53
|
38
|
38
|
36
|
40
|
38
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
1
|
3
|
5
|
2
|
0
|
1
|
2
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
1
|
4
|
3
|
1
|
1
|
0
|
2
|
3
|
2
|
3
|
3
|
2
|
4
|
2
|
2
|
1
|
5
|
Reasons for withdrawal
| Measure |
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A13: Influenza Vaccine 2
Participants received a single IM injection of Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
2
|
1
|
3
|
4
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
2
|
0
|
0
|
0
|
1
|
2
|
1
|
1
|
2
|
1
|
4
|
1
|
2
|
1
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other Than Specified
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Total
n=1743 Participants
Total of all reporting groups
|
Part 1 Cohort A12: Influenza Vaccine 1
n=54 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A13: Influenza Vaccine 2
n=53 Participants
Participants received a single IM injection of Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A11: Investigational Influenza Vaccine 2
n=54 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A8: Investigational Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A10: COVID-19 Vaccine 1
n=54 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
n=52 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
n=51 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
n=54 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
n=54 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=55 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=56 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=55 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=55 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=54 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 Participants
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Race · Black or African American
|
6 Participants
n=674 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=28 Participants
|
9 Participants
n=1034 Participants
|
13 Participants
n=8 Participants
|
7 Participants
n=3 Participants
|
13 Participants
n=3 Participants
|
9 Participants
n=119 Participants
|
330 Participants
n=1743 Participants
|
6 Participants
n=68 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=219 Participants
|
6 Participants
n=219 Participants
|
9 Participants
n=880 Participants
|
7 Participants
n=6 Participants
|
5 Participants
n=23 Participants
|
5 Participants
n=35 Participants
|
5 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=14 Participants
|
6 Participants
n=15 Participants
|
13 Participants
n=16 Participants
|
12 Participants
n=13 Participants
|
7 Participants
n=16 Participants
|
14 Participants
n=14 Participants
|
12 Participants
n=15 Participants
|
11 Participants
n=14 Participants
|
16 Participants
n=20 Participants
|
3 Participants
n=25 Participants
|
11 Participants
n=7 Participants
|
11 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=412 Participants
|
7 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=70 Participants
|
10 Participants
n=122 Participants
|
7 Participants
n=60 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
0 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=674 Participants
|
42 Participants
n=31 Participants
|
41 Participants
n=28 Participants
|
41 Participants
n=1034 Participants
|
40 Participants
n=8 Participants
|
40 Participants
n=3 Participants
|
40 Participants
n=3 Participants
|
42 Participants
n=119 Participants
|
1147 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
52 Participants
n=16 Participants
|
55 Participants
n=13 Participants
|
55 Participants
n=16 Participants
|
53 Participants
n=14 Participants
|
55 Participants
n=15 Participants
|
55 Participants
n=14 Participants
|
56 Participants
n=20 Participants
|
37 Participants
n=25 Participants
|
55 Participants
n=7 Participants
|
55 Participants
|
38 Participants
n=4 Participants
|
54 Participants
n=412 Participants
|
40 Participants
n=10 Participants
|
39 Participants
n=10 Participants
|
40 Participants
n=70 Participants
|
42 Participants
n=122 Participants
|
40 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
596 Participants
n=1743 Participants
|
54 Participants
n=68 Participants
|
53 Participants
n=4 Participants
|
54 Participants
n=219 Participants
|
51 Participants
n=219 Participants
|
54 Participants
n=880 Participants
|
52 Participants
n=6 Participants
|
51 Participants
n=23 Participants
|
33 Participants
n=35 Participants
|
54 Participants
n=15 Participants
|
54 Participants
n=14 Participants
|
33 Participants
n=14 Participants
|
53 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=674 Participants
|
21 Participants
n=31 Participants
|
22 Participants
n=28 Participants
|
18 Participants
n=1034 Participants
|
23 Participants
n=8 Participants
|
25 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
23 Participants
n=119 Participants
|
941 Participants
n=1743 Participants
|
32 Participants
n=68 Participants
|
30 Participants
n=4 Participants
|
29 Participants
n=219 Participants
|
29 Participants
n=219 Participants
|
33 Participants
n=880 Participants
|
30 Participants
n=6 Participants
|
27 Participants
n=23 Participants
|
16 Participants
n=35 Participants
|
30 Participants
n=15 Participants
|
30 Participants
n=14 Participants
|
14 Participants
n=14 Participants
|
28 Participants
n=15 Participants
|
32 Participants
n=16 Participants
|
23 Participants
n=13 Participants
|
31 Participants
n=16 Participants
|
29 Participants
n=14 Participants
|
28 Participants
n=15 Participants
|
28 Participants
n=14 Participants
|
31 Participants
n=20 Participants
|
17 Participants
n=25 Participants
|
33 Participants
n=7 Participants
|
31 Participants
|
24 Participants
n=4 Participants
|
30 Participants
n=412 Participants
|
23 Participants
n=10 Participants
|
20 Participants
n=10 Participants
|
24 Participants
n=70 Participants
|
18 Participants
n=122 Participants
|
15 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=674 Participants
|
21 Participants
n=31 Participants
|
19 Participants
n=28 Participants
|
23 Participants
n=1034 Participants
|
17 Participants
n=8 Participants
|
15 Participants
n=3 Participants
|
18 Participants
n=3 Participants
|
19 Participants
n=119 Participants
|
802 Participants
n=1743 Participants
|
22 Participants
n=68 Participants
|
23 Participants
n=4 Participants
|
25 Participants
n=219 Participants
|
22 Participants
n=219 Participants
|
21 Participants
n=880 Participants
|
22 Participants
n=6 Participants
|
24 Participants
n=23 Participants
|
17 Participants
n=35 Participants
|
24 Participants
n=15 Participants
|
24 Participants
n=14 Participants
|
19 Participants
n=14 Participants
|
25 Participants
n=15 Participants
|
20 Participants
n=16 Participants
|
32 Participants
n=13 Participants
|
24 Participants
n=16 Participants
|
24 Participants
n=14 Participants
|
27 Participants
n=15 Participants
|
27 Participants
n=14 Participants
|
25 Participants
n=20 Participants
|
20 Participants
n=25 Participants
|
22 Participants
n=7 Participants
|
24 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=412 Participants
|
17 Participants
n=10 Participants
|
19 Participants
n=10 Participants
|
16 Participants
n=70 Participants
|
24 Participants
n=122 Participants
|
25 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=674 Participants
|
10 Participants
n=31 Participants
|
11 Participants
n=28 Participants
|
2 Participants
n=1034 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=3 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=119 Participants
|
209 Participants
n=1743 Participants
|
4 Participants
n=68 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=219 Participants
|
3 Participants
n=219 Participants
|
4 Participants
n=880 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=23 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
3 Participants
n=14 Participants
|
8 Participants
n=15 Participants
|
8 Participants
n=16 Participants
|
2 Participants
n=13 Participants
|
8 Participants
n=16 Participants
|
7 Participants
n=14 Participants
|
4 Participants
n=15 Participants
|
7 Participants
n=14 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=25 Participants
|
9 Participants
n=7 Participants
|
7 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=412 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=70 Participants
|
2 Participants
n=122 Participants
|
8 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=674 Participants
|
32 Participants
n=31 Participants
|
29 Participants
n=28 Participants
|
38 Participants
n=1034 Participants
|
34 Participants
n=8 Participants
|
30 Participants
n=3 Participants
|
34 Participants
n=3 Participants
|
35 Participants
n=119 Participants
|
1517 Participants
n=1743 Participants
|
50 Participants
n=68 Participants
|
49 Participants
n=4 Participants
|
47 Participants
n=219 Participants
|
47 Participants
n=219 Participants
|
50 Participants
n=880 Participants
|
44 Participants
n=6 Participants
|
43 Participants
n=23 Participants
|
28 Participants
n=35 Participants
|
49 Participants
n=15 Participants
|
49 Participants
n=14 Participants
|
30 Participants
n=14 Participants
|
45 Participants
n=15 Participants
|
44 Participants
n=16 Participants
|
51 Participants
n=13 Participants
|
47 Participants
n=16 Participants
|
46 Participants
n=14 Participants
|
51 Participants
n=15 Participants
|
47 Participants
n=14 Participants
|
50 Participants
n=20 Participants
|
32 Participants
n=25 Participants
|
46 Participants
n=7 Participants
|
48 Participants
|
33 Participants
n=4 Participants
|
48 Participants
n=412 Participants
|
33 Participants
n=10 Participants
|
35 Participants
n=10 Participants
|
36 Participants
n=70 Participants
|
40 Participants
n=122 Participants
|
32 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=1034 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=119 Participants
|
17 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
29 Participants
n=674 Participants
|
26 Participants
n=31 Participants
|
24 Participants
n=28 Participants
|
24 Participants
n=1034 Participants
|
22 Participants
n=8 Participants
|
22 Participants
n=3 Participants
|
22 Participants
n=3 Participants
|
29 Participants
n=119 Participants
|
1277 Participants
n=1743 Participants
|
48 Participants
n=68 Participants
|
47 Participants
n=4 Participants
|
46 Participants
n=219 Participants
|
44 Participants
n=219 Participants
|
44 Participants
n=880 Participants
|
43 Participants
n=6 Participants
|
46 Participants
n=23 Participants
|
28 Participants
n=35 Participants
|
45 Participants
n=15 Participants
|
50 Participants
n=14 Participants
|
27 Participants
n=14 Participants
|
45 Participants
n=15 Participants
|
38 Participants
n=16 Participants
|
39 Participants
n=13 Participants
|
43 Participants
n=16 Participants
|
36 Participants
n=14 Participants
|
37 Participants
n=15 Participants
|
36 Participants
n=14 Participants
|
37 Participants
n=20 Participants
|
30 Participants
n=25 Participants
|
41 Participants
n=7 Participants
|
39 Participants
|
22 Participants
n=4 Participants
|
37 Participants
n=412 Participants
|
29 Participants
n=10 Participants
|
26 Participants
n=10 Participants
|
25 Participants
n=70 Participants
|
26 Participants
n=122 Participants
|
25 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=674 Participants
|
4 Participants
n=31 Participants
|
5 Participants
n=28 Participants
|
6 Participants
n=1034 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=119 Participants
|
90 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
1 Participants
n=219 Participants
|
1 Participants
n=880 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=13 Participants
|
4 Participants
n=16 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=15 Participants
|
4 Participants
n=14 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
4 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=412 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
3 Participants
n=70 Participants
|
5 Participants
n=122 Participants
|
4 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
4 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=674 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
5 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
1 Participants
n=674 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=1034 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
14 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
14 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=7 Participants
|
1 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
0 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=119 Participants
|
1 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=674 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=28 Participants
|
0 Participants
n=1034 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=119 Participants
|
8 Participants
n=1743 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=219 Participants
|
0 Participants
n=880 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=7 Participants
|
0 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=122 Participants
|
2 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days after study injectionPopulation: The solicited safety set included all randomized participants who receive the study intervention and contribute any solicited AR data. Participants were included in the vaccination group corresponding to what they actually received (as treated).
Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=53 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=52 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=55 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=54 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=55 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=54 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 Participants
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
|
36 Participants
|
37 Participants
|
43 Participants
|
42 Participants
|
31 Participants
|
44 Participants
|
26 Participants
|
42 Participants
|
46 Participants
|
32 Participants
|
29 Participants
|
38 Participants
|
33 Participants
|
34 Participants
|
37 Participants
|
39 Participants
|
46 Participants
|
33 Participants
|
49 Participants
|
51 Participants
|
46 Participants
|
41 Participants
|
47 Participants
|
50 Participants
|
34 Participants
|
46 Participants
|
51 Participants
|
38 Participants
|
47 Participants
|
32 Participants
|
32 Participants
|
39 Participants
|
40 Participants
|
34 Participants
|
34 Participants
|
39 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days after study injectionPopulation: The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=53 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=52 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=55 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=54 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=55 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=54 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=54 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 Participants
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs
Unsolicited AEs
|
9 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs
Severe AEs
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 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
|
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
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 181Population: The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were protocol-defined medical concepts. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=53 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=54 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=52 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=55 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=54 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=55 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=56 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=54 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=54 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 Participants
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
SAEs
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
MAAEs
|
16 Participants
|
13 Participants
|
16 Participants
|
13 Participants
|
20 Participants
|
12 Participants
|
4 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
7 Participants
|
6 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
17 Participants
|
17 Participants
|
15 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
13 Participants
|
12 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
|
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
AEs Leading to Study Discontinuation
|
0 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
|
0 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
|
0 Participants
|
0 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation
AESIs
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=37 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=38 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H1N1 Antibody
|
105.1 titer
Interval 71.9 to 153.7
|
129.0 titer
Interval 86.2 to 193.1
|
73.9 titer
Interval 52.6 to 103.6
|
98.3 titer
Interval 71.3 to 135.5
|
111.2 titer
Interval 81.2 to 152.5
|
99.9 titer
Interval 69.6 to 143.4
|
85.7 titer
Interval 61.0 to 120.4
|
88.4 titer
Interval 64.3 to 121.5
|
71.2 titer
Interval 47.6 to 106.7
|
80.0 titer
Interval 50.3 to 127.2
|
106.0 titer
Interval 73.3 to 153.2
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza A H3N2 Antibody
|
96.0 titer
Interval 66.3 to 139.1
|
155.6 titer
Interval 111.4 to 217.3
|
65.8 titer
Interval 50.3 to 86.1
|
71.3 titer
Interval 53.9 to 94.2
|
105.6 titer
Interval 80.2 to 139.0
|
79.3 titer
Interval 59.5 to 105.7
|
62.2 titer
Interval 45.5 to 85.1
|
79.3 titer
Interval 61.8 to 101.7
|
75.2 titer
Interval 54.0 to 104.5
|
80.7 titer
Interval 60.9 to 107.0
|
80.7 titer
Interval 64.5 to 100.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B/Victoria-lineage Antibody
|
80.7 titer
Interval 59.5 to 109.5
|
141.9 titer
Interval 100.3 to 200.8
|
75.8 titer
Interval 57.4 to 100.2
|
104.2 titer
Interval 81.1 to 133.8
|
108.4 titer
Interval 84.2 to 139.5
|
106.3 titer
Interval 76.4 to 147.9
|
98.5 titer
Interval 72.2 to 134.3
|
78.5 titer
Interval 61.3 to 100.6
|
75.9 titer
Interval 56.7 to 101.6
|
86.0 titer
Interval 67.7 to 109.2
|
82.0 titer
Interval 63.8 to 105.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Influenza B/Yamagata-lineage Antibody
|
122.8 titer
Interval 99.2 to 151.9
|
179.0 titer
Interval 130.4 to 245.7
|
80.7 titer
Interval 64.1 to 101.7
|
101.6 titer
Interval 80.0 to 129.0
|
112.2 titer
Interval 87.8 to 143.3
|
112.2 titer
Interval 90.1 to 139.7
|
94.3 titer
Interval 69.6 to 127.9
|
118.3 titer
Interval 87.4 to 160.3
|
97.7 titer
Interval 74.8 to 127.5
|
140.8 titer
Interval 110.2 to 179.9
|
98.3 titer
Interval 76.5 to 126.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)
|
1939.7 AU/mL
Interval 1366.0 to 2754.4
|
427.6 AU/mL
Interval 302.9 to 603.7
|
901.0 AU/mL
Interval 655.9 to 1237.6
|
882.0 AU/mL
Interval 630.5 to 1233.9
|
1108.3 AU/mL
Interval 801.9 to 1531.7
|
679.7 AU/mL
Interval 451.4 to 1023.4
|
878.7 AU/mL
Interval 640.1 to 1206.2
|
904.8 AU/mL
Interval 576.5 to 1420.1
|
1083.7 AU/mL
Interval 744.2 to 1578.3
|
1567.0 AU/mL
Interval 1134.6 to 2164.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=37 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=38 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
3.5 ratio
Interval 2.5 to 4.8
|
3.7 ratio
Interval 2.6 to 5.2
|
1.8 ratio
Interval 1.4 to 2.2
|
2.2 ratio
Interval 1.7 to 2.8
|
2.7 ratio
Interval 1.9 to 3.9
|
2.0 ratio
Interval 1.6 to 2.5
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1.9 ratio
Interval 1.3 to 2.7
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2.7 ratio
Interval 2.0 to 3.7
|
2.3 ratio
Interval 1.6 to 3.1
|
2.6 ratio
Interval 1.8 to 3.9
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2.9 ratio
Interval 2.2 to 3.7
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Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
2.6 ratio
Interval 2.1 to 3.3
|
3.4 ratio
Interval 2.5 to 4.6
|
1.8 ratio
Interval 1.4 to 2.3
|
1.9 ratio
Interval 1.6 to 2.4
|
2.3 ratio
Interval 1.7 to 3.1
|
2.0 ratio
Interval 1.5 to 2.7
|
1.7 ratio
Interval 1.4 to 2.1
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2.3 ratio
Interval 1.9 to 2.7
|
1.8 ratio
Interval 1.3 to 2.4
|
2.8 ratio
Interval 2.2 to 3.7
|
2.7 ratio
Interval 2.2 to 3.3
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—
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—
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|
Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody
|
2.0 ratio
Interval 1.5 to 2.6
|
2.4 ratio
Interval 1.7 to 3.2
|
1.4 ratio
Interval 1.2 to 1.7
|
1.6 ratio
Interval 1.3 to 1.9
|
1.7 ratio
Interval 1.5 to 2.1
|
2.1 ratio
Interval 1.7 to 2.6
|
1.5 ratio
Interval 1.2 to 1.8
|
1.5 ratio
Interval 1.3 to 1.7
|
1.5 ratio
Interval 1.3 to 1.9
|
1.7 ratio
Interval 1.4 to 2.1
|
1.7 ratio
Interval 1.4 to 2.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody
|
2.3 ratio
Interval 1.8 to 2.8
|
2.1 ratio
Interval 1.7 to 2.7
|
1.3 ratio
Interval 1.1 to 1.5
|
1.4 ratio
Interval 1.2 to 1.7
|
1.6 ratio
Interval 1.3 to 2.0
|
1.6 ratio
Interval 1.4 to 1.9
|
1.3 ratio
Interval 1.1 to 1.6
|
1.6 ratio
Interval 1.3 to 2.0
|
1.4 ratio
Interval 1.2 to 1.8
|
1.7 ratio
Interval 1.4 to 2.2
|
1.6 ratio
Interval 1.3 to 1.8
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
PRIMARY outcome
Timeframe: Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA
|
9.1 ratio
Interval 5.4 to 15.2
|
3.3 ratio
Interval 2.1 to 5.2
|
5.4 ratio
Interval 3.5 to 8.1
|
4.4 ratio
Interval 2.9 to 6.9
|
3.6 ratio
Interval 2.5 to 5.1
|
4.5 ratio
Interval 2.9 to 6.9
|
4.1 ratio
Interval 2.9 to 6.0
|
7.1 ratio
Interval 4.4 to 11.4
|
8.0 ratio
Interval 5.4 to 11.7
|
5.4 ratio
Interval 3.3 to 8.7
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=37 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=38 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
36.8 percentage of participants
Interval 21.8 to 54.0
|
43.2 percentage of participants
Interval 27.1 to 60.5
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
23.8 percentage of participants
Interval 12.1 to 39.5
|
27.5 percentage of participants
Interval 14.6 to 43.9
|
23.1 percentage of participants
Interval 11.1 to 39.3
|
15.0 percentage of participants
Interval 5.7 to 29.8
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
21.2 percentage of participants
Interval 9.0 to 38.9
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
42.9 percentage of participants
Interval 27.7 to 59.0
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
50.0 percentage of participants
Interval 33.4 to 66.6
|
51.4 percentage of participants
Interval 34.4 to 68.1
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
31.0 percentage of participants
Interval 17.6 to 47.1
|
30.0 percentage of participants
Interval 16.6 to 46.5
|
25.6 percentage of participants
Interval 13.0 to 42.1
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
34.2 percentage of participants
Interval 19.6 to 51.4
|
30.3 percentage of participants
Interval 15.6 to 48.7
|
31.6 percentage of participants
Interval 17.5 to 48.7
|
35.7 percentage of participants
Interval 21.6 to 52.0
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
|
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody
|
15.8 percentage of participants
Interval 6.0 to 31.3
|
27.0 percentage of participants
Interval 13.8 to 44.1
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
9.5 percentage of participants
Interval 2.7 to 22.6
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
23.1 percentage of participants
Interval 11.1 to 39.3
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
15.8 percentage of participants
Interval 6.0 to 31.3
|
11.9 percentage of participants
Interval 4.0 to 25.6
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
|
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody
|
26.3 percentage of participants
Interval 13.4 to 43.1
|
27.0 percentage of participants
Interval 13.8 to 44.1
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
9.5 percentage of participants
Interval 2.7 to 22.6
|
12.5 percentage of participants
Interval 4.2 to 26.8
|
7.7 percentage of participants
Interval 1.6 to 20.9
|
17.5 percentage of participants
Interval 7.3 to 32.8
|
13.2 percentage of participants
Interval 4.4 to 28.1
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
21.1 percentage of participants
Interval 9.6 to 37.3
|
4.8 percentage of participants
Interval 0.6 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to Day 29Population: PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline neutralizing antibody (nAb) level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
|
57.9 percentage of participants
Interval 40.8 to 73.7
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
52.4 percentage of participants
Interval 36.4 to 68.0
|
47.5 percentage of participants
Interval 31.5 to 63.9
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
50.0 percentage of participants
Interval 33.8 to 66.2
|
44.7 percentage of participants
Interval 28.6 to 61.7
|
63.6 percentage of participants
Interval 45.1 to 79.6
|
69.0 percentage of participants
Interval 52.9 to 82.4
|
55.0 percentage of participants
Interval 38.5 to 70.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/ Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=49 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=45 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=47 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=51 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=53 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=36 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=52 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=51 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 1
|
34.1 titer
Interval 26.5 to 43.9
|
38.9 titer
Interval 29.3 to 51.5
|
30.7 titer
Interval 23.0 to 41.0
|
43.1 titer
Interval 33.9 to 54.9
|
31.7 titer
Interval 22.4 to 44.8
|
29.0 titer
Interval 21.4 to 39.5
|
37.6 titer
Interval 27.4 to 51.5
|
39.6 titer
Interval 28.3 to 55.2
|
32.1 titer
Interval 24.0 to 43.0
|
34.4 titer
Interval 25.5 to 46.6
|
27.5 titer
Interval 21.3 to 35.5
|
—
|
—
|
—
|
—
|
—
|
48.3 titer
Interval 34.7 to 67.3
|
43.9 titer
Interval 33.2 to 58.1
|
38.9 titer
Interval 29.9 to 50.6
|
30.0 titer
Interval 23.9 to 37.6
|
36.0 titer
Interval 26.1 to 49.7
|
32.0 titer
Interval 23.4 to 43.9
|
43.0 titer
Interval 31.3 to 59.2
|
34.8 titer
Interval 25.9 to 46.7
|
33.2 titer
Interval 25.3 to 43.4
|
—
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—
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—
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|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 29
|
85.7 titer
Interval 62.9 to 116.8
|
108.5 titer
Interval 84.0 to 140.1
|
149.3 titer
Interval 107.5 to 207.3
|
95.8 titer
Interval 74.8 to 122.8
|
104.3 titer
Interval 69.4 to 156.8
|
106.0 titer
Interval 81.5 to 137.9
|
139.5 titer
Interval 99.9 to 194.9
|
82.7 titer
Interval 56.3 to 121.3
|
129.1 titer
Interval 99.9 to 166.8
|
78.4 titer
Interval 60.9 to 100.8
|
114.0 titer
Interval 82.1 to 158.3
|
—
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—
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—
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—
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—
|
145.3 titer
Interval 105.1 to 200.9
|
138.2 titer
Interval 101.7 to 187.7
|
126.4 titer
Interval 98.3 to 162.5
|
120.8 titer
Interval 89.7 to 162.6
|
135.9 titer
Interval 101.5 to 181.9
|
177.6 titer
Interval 135.6 to 232.4
|
142.9 titer
Interval 115.1 to 177.3
|
196.7 titer
Interval 138.2 to 280.1
|
150.5 titer
Interval 115.0 to 197.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 181
|
104.7 titer
Interval 74.8 to 146.7
|
99.3 titer
Interval 74.0 to 133.3
|
148.1 titer
Interval 99.2 to 221.1
|
104.3 titer
Interval 77.6 to 140.3
|
145.6 titer
Interval 104.1 to 203.7
|
127.3 titer
Interval 96.2 to 168.5
|
135.3 titer
Interval 102.4 to 178.7
|
104.2 titer
Interval 73.7 to 147.2
|
140.2 titer
Interval 108.9 to 180.5
|
104.5 titer
Interval 80.1 to 136.3
|
118.4 titer
Interval 88.4 to 158.7
|
—
|
—
|
—
|
—
|
—
|
140.6 titer
Interval 108.1 to 182.8
|
174.5 titer
Interval 137.5 to 221.5
|
134.5 titer
Interval 104.6 to 173.0
|
147.9 titer
Interval 113.0 to 193.5
|
157.9 titer
Interval 111.4 to 223.8
|
176.3 titer
Interval 134.6 to 230.8
|
132.5 titer
Interval 105.9 to 165.9
|
156.1 titer
Interval 114.5 to 212.9
|
161.2 titer
Interval 121.6 to 213.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 29
|
67.7 titer
Interval 48.9 to 93.8
|
88.3 titer
Interval 65.7 to 118.6
|
113.2 titer
Interval 77.6 to 165.0
|
90.7 titer
Interval 65.6 to 125.2
|
119.8 titer
Interval 74.9 to 191.7
|
64.8 titer
Interval 47.8 to 87.9
|
103.4 titer
Interval 78.1 to 136.9
|
94.6 titer
Interval 63.8 to 140.2
|
100.6 titer
Interval 75.5 to 134.1
|
61.8 titer
Interval 45.6 to 83.8
|
64.5 titer
Interval 45.8 to 90.9
|
—
|
—
|
—
|
—
|
—
|
111.5 titer
Interval 84.8 to 146.7
|
117.8 titer
Interval 83.2 to 166.6
|
105.6 titer
Interval 79.4 to 140.3
|
73.0 titer
Interval 52.9 to 100.8
|
104.8 titer
Interval 70.3 to 156.0
|
116.3 titer
Interval 84.2 to 160.6
|
107.2 titer
Interval 77.7 to 147.8
|
93.8 titer
Interval 66.2 to 132.9
|
110.8 titer
Interval 78.8 to 155.9
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 181
|
87.2 titer
Interval 63.2 to 120.3
|
116.9 titer
Interval 80.0 to 170.7
|
146.7 titer
Interval 99.3 to 216.9
|
129.8 titer
Interval 96.2 to 175.2
|
196.4 titer
Interval 125.1 to 308.5
|
91.5 titer
Interval 71.5 to 117.0
|
114.2 titer
Interval 81.4 to 160.2
|
107.2 titer
Interval 72.5 to 158.5
|
117.9 titer
Interval 87.1 to 159.6
|
85.1 titer
Interval 64.2 to 112.9
|
83.2 titer
Interval 64.9 to 106.6
|
—
|
—
|
—
|
—
|
—
|
111.2 titer
Interval 87.2 to 141.9
|
140.0 titer
Interval 93.9 to 208.6
|
129.4 titer
Interval 99.5 to 168.4
|
102.1 titer
Interval 73.7 to 141.5
|
149.3 titer
Interval 95.1 to 234.2
|
120.8 titer
Interval 87.8 to 166.2
|
145.7 titer
Interval 111.0 to 191.2
|
111.7 titer
Interval 79.7 to 156.7
|
134.1 titer
Interval 98.6 to 182.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 1
|
49.2 titer
Interval 35.8 to 67.8
|
46.7 titer
Interval 34.0 to 64.2
|
46.8 titer
Interval 34.5 to 63.4
|
73.1 titer
Interval 56.4 to 94.7
|
52.2 titer
Interval 36.7 to 74.3
|
72.5 titer
Interval 56.2 to 93.7
|
55.0 titer
Interval 41.3 to 73.0
|
46.8 titer
Interval 32.5 to 67.3
|
69.6 titer
Interval 52.3 to 92.8
|
55.4 titer
Interval 41.3 to 74.3
|
34.5 titer
Interval 25.7 to 46.4
|
—
|
—
|
—
|
—
|
—
|
33.1 titer
Interval 23.5 to 46.6
|
31.5 titer
Interval 23.3 to 42.6
|
37.6 titer
Interval 28.5 to 49.6
|
39.0 titer
Interval 29.2 to 52.0
|
34.3 titer
Interval 23.3 to 50.4
|
35.3 titer
Interval 25.1 to 49.5
|
36.9 titer
Interval 28.2 to 48.4
|
33.0 titer
Interval 24.7 to 44.1
|
39.4 titer
Interval 28.6 to 54.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 29
|
106.3 titer
Interval 72.7 to 155.3
|
88.3 titer
Interval 65.3 to 119.4
|
151.5 titer
Interval 120.5 to 190.5
|
141.2 titer
Interval 107.9 to 184.9
|
128.5 titer
Interval 82.0 to 201.3
|
148.0 titer
Interval 115.3 to 189.9
|
155.5 titer
Interval 121.1 to 199.6
|
152.9 titer
Interval 106.7 to 219.1
|
172.7 titer
Interval 131.9 to 226.0
|
100.7 titer
Interval 70.1 to 144.8
|
83.4 titer
Interval 58.7 to 118.6
|
—
|
—
|
—
|
—
|
—
|
59.1 titer
Interval 44.7 to 78.2
|
83.8 titer
Interval 59.7 to 117.6
|
76.8 titer
Interval 59.5 to 99.1
|
96.7 titer
Interval 70.2 to 133.0
|
89.0 titer
Interval 62.1 to 127.7
|
76.1 titer
Interval 55.1 to 105.2
|
113.1 titer
Interval 82.1 to 155.9
|
91.2 titer
Interval 65.2 to 127.7
|
93.5 titer
Interval 67.1 to 130.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 181
|
128.2 titer
Interval 86.3 to 190.6
|
95.1 titer
Interval 68.6 to 131.9
|
139.9 titer
Interval 108.0 to 181.1
|
140.6 titer
Interval 106.9 to 184.8
|
178.8 titer
Interval 110.4 to 289.4
|
174.5 titer
Interval 136.2 to 223.6
|
142.5 titer
Interval 101.1 to 200.9
|
183.7 titer
Interval 122.6 to 275.4
|
185.7 titer
Interval 136.2 to 253.1
|
167.2 titer
Interval 113.6 to 246.2
|
103.2 titer
Interval 77.5 to 137.4
|
—
|
—
|
—
|
—
|
—
|
81.3 titer
Interval 58.0 to 113.9
|
115.9 titer
Interval 82.1 to 163.6
|
115.9 titer
Interval 86.8 to 154.6
|
126.3 titer
Interval 97.6 to 163.5
|
82.2 titer
Interval 53.0 to 127.5
|
86.0 titer
Interval 64.1 to 115.4
|
93.8 titer
Interval 73.0 to 120.4
|
99.9 titer
Interval 64.2 to 155.6
|
112.3 titer
Interval 81.4 to 155.0
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 1
|
56.5 titer
Interval 43.0 to 74.3
|
62.9 titer
Interval 46.5 to 85.0
|
52.7 titer
Interval 39.7 to 70.0
|
80.6 titer
Interval 65.0 to 99.9
|
63.5 titer
Interval 45.3 to 88.9
|
74.5 titer
Interval 57.2 to 96.9
|
56.5 titer
Interval 42.8 to 74.7
|
48.4 titer
Interval 33.1 to 70.7
|
90.6 titer
Interval 68.8 to 119.4
|
49.0 titer
Interval 36.9 to 65.2
|
78.3 titer
Interval 62.4 to 98.3
|
—
|
—
|
—
|
—
|
—
|
94.1 titer
Interval 74.0 to 119.6
|
85.5 titer
Interval 66.5 to 110.0
|
100.1 titer
Interval 74.0 to 135.4
|
91.1 titer
Interval 67.9 to 122.2
|
81.6 titer
Interval 60.9 to 109.3
|
74.7 titer
Interval 57.8 to 96.5
|
88.5 titer
Interval 67.6 to 115.8
|
101.1 titer
Interval 71.0 to 143.9
|
84.0 titer
Interval 62.2 to 113.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 29
|
110.0 titer
Interval 83.3 to 145.3
|
100.4 titer
Interval 75.9 to 132.8
|
108.1 titer
Interval 82.3 to 141.9
|
110.8 titer
Interval 86.9 to 141.3
|
101.9 titer
Interval 69.0 to 150.4
|
112.3 titer
Interval 83.3 to 151.5
|
98.7 titer
Interval 75.9 to 128.1
|
80.0 titer
Interval 56.5 to 113.3
|
145.2 titer
Interval 109.5 to 192.7
|
75.2 titer
Interval 56.2 to 100.7
|
151.4 titer
Interval 108.7 to 210.8
|
—
|
—
|
—
|
—
|
—
|
165.9 titer
Interval 132.4 to 208.0
|
176.7 titer
Interval 129.5 to 241.3
|
185.0 titer
Interval 134.8 to 253.9
|
178.0 titer
Interval 139.7 to 226.7
|
145.3 titer
Interval 100.5 to 210.0
|
154.5 titer
Interval 118.2 to 202.0
|
181.5 titer
Interval 139.6 to 236.1
|
246.1 titer
Interval 175.8 to 344.6
|
154.7 titer
Interval 113.5 to 210.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 181
|
112.0 titer
Interval 78.2 to 160.5
|
84.5 titer
Interval 56.5 to 126.4
|
98.9 titer
Interval 68.6 to 142.5
|
109.6 titer
Interval 80.9 to 148.4
|
109.6 titer
Interval 71.7 to 167.6
|
98.9 titer
Interval 74.0 to 132.3
|
98.1 titer
Interval 68.4 to 140.9
|
87.3 titer
Interval 53.2 to 143.1
|
121.9 titer
Interval 87.6 to 169.6
|
94.8 titer
Interval 65.4 to 137.4
|
88.4 titer
Interval 66.6 to 117.3
|
—
|
—
|
—
|
—
|
—
|
91.8 titer
Interval 69.2 to 121.8
|
121.4 titer
Interval 89.6 to 164.5
|
129.8 titer
Interval 95.6 to 176.1
|
121.4 titer
Interval 91.5 to 161.0
|
75.7 titer
Interval 50.2 to 114.1
|
112.2 titer
Interval 78.5 to 160.4
|
95.2 titer
Interval 72.9 to 124.1
|
111.7 titer
Interval 76.6 to 162.9
|
88.4 titer
Interval 66.6 to 117.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 1
|
47.5 titer
Interval 36.9 to 61.2
|
55.0 titer
Interval 42.3 to 71.6
|
55.7 titer
Interval 43.3 to 71.6
|
58.2 titer
Interval 46.3 to 73.1
|
41.4 titer
Interval 29.0 to 59.2
|
55.1 titer
Interval 41.1 to 73.9
|
53.1 titer
Interval 39.5 to 71.3
|
39.1 titer
Interval 29.7 to 51.6
|
57.7 titer
Interval 46.1 to 72.4
|
49.7 titer
Interval 40.4 to 61.1
|
48.3 titer
Interval 38.5 to 60.6
|
—
|
—
|
—
|
—
|
—
|
61.8 titer
Interval 47.2 to 81.0
|
48.9 titer
Interval 38.8 to 61.7
|
51.4 titer
Interval 38.5 to 68.8
|
57.3 titer
Interval 45.6 to 72.0
|
59.4 titer
Interval 44.2 to 79.7
|
52.7 titer
Interval 40.8 to 68.2
|
58.5 titer
Interval 47.0 to 72.8
|
77.0 titer
Interval 55.9 to 106.1
|
58.5 titer
Interval 44.8 to 76.3
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 29, and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GM titer, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=49 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=36 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=38 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=51 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 1
|
574.1 titer
Interval 352.8 to 848.2
|
616.9 titer
Interval 367.1 to 1036.8
|
585.9 titer
Interval 314.7 to 1090.6
|
646.6 titer
Interval 408.8 to 1022.7
|
536.3 titer
Interval 329.5 to 872.7
|
1008.2 titer
Interval 616.1 to 1649.7
|
883.2 titer
Interval 584.9 to 1333.6
|
384.1 titer
Interval 251.4 to 586.8
|
469.8 titer
Interval 297.5 to 741.8
|
618.0 titer
Interval 403.0 to 947.9
|
653.7 titer
Interval 442.5 to 965.8
|
—
|
—
|
—
|
—
|
—
|
440.5 titer
Interval 295.7 to 656.3
|
487.5 titer
Interval 283.4 to 838.4
|
469.1 titer
Interval 292.1 to 753.2
|
524.8 titer
Interval 361.7 to 761.5
|
301.8 titer
Interval 195.0 to 467.1
|
489.8 titer
Interval 320.9 to 747.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 29
|
5476.9 titer
Interval 3988.2 to 7521.5
|
4636.7 titer
Interval 3098.6 to 6938.3
|
5387.3 titer
Interval 3207.7 to 9047.8
|
3706.0 titer
Interval 2656.8 to 5169.4
|
3669.6 titer
Interval 2577.8 to 5223.8
|
5647.8 titer
Interval 4227.0 to 7546.2
|
4120.6 titer
Interval 3224.4 to 5265.8
|
2635.8 titer
Interval 1973.8 to 3519.9
|
4743.9 titer
Interval 3529.0 to 6377.1
|
4536.9 titer
Interval 3147.0 to 6540.8
|
4005.9 titer
Interval 3131.4 to 5124.5
|
—
|
—
|
—
|
—
|
—
|
3061.1 titer
Interval 2308.3 to 4059.2
|
3599.0 titer
Interval 2577.6 to 5025.1
|
3425.6 titer
Interval 2558.6 to 4586.4
|
4391.3 titer
Interval 3488.0 to 5528.4
|
3119.7 titer
Interval 2360.0 to 4124.0
|
3458.4 titer
Interval 2595.9 to 4607.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 181
|
2524.4 titer
Interval 1588.3 to 4012.3
|
1793.9 titer
Interval 1145.8 to 2808.5
|
1851.8 titer
Interval 899.5 to 3812.3
|
1461.3 titer
Interval 945.9 to 2257.6
|
1552.5 titer
Interval 935.1 to 2577.6
|
2185.7 titer
Interval 1425.4 to 3351.4
|
1480.3 titer
Interval 980.2 to 2235.6
|
1443.0 titer
Interval 1049.6 to 1983.9
|
1972.1 titer
Interval 1305.9 to 2978.2
|
1500.1 titer
Interval 977.6 to 2301.8
|
1595.9 titer
Interval 1167.3 to 2181.8
|
—
|
—
|
—
|
—
|
—
|
1225.0 titer
Interval 861.6 to 1741.6
|
1657.5 titer
Interval 999.9 to 2747.5
|
1413.4 titer
Interval 936.8 to 2132.5
|
1792.7 titer
Interval 1311.6 to 2450.4
|
1042.8 titer
Interval 620.3 to 1753.1
|
1270.3 titer
Interval 888.8 to 1815.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 1
|
2176.0 titer
Interval 1546.4 to 3062.0
|
2362.5 titer
Interval 1525.7 to 3658.3
|
2578.4 titer
Interval 1482.4 to 4484.8
|
2992.6 titer
Interval 2118.7 to 4226.9
|
2091.1 titer
Interval 1408.0 to 3105.7
|
3284.9 titer
Interval 2260.6 to 4773.3
|
2909.8 titer
Interval 2255.8 to 3753.4
|
1548.5 titer
Interval 1057.5 to 2267.5
|
1756.8 titer
Interval 1185.2 to 2604.2
|
2052.1 titer
Interval 1472.4 to 2860.0
|
2328.9 titer
Interval 1776.8 to 3052.6
|
—
|
—
|
—
|
—
|
—
|
1994.9 titer
Interval 1476.1 to 2696.1
|
1553.2 titer
Interval 1011.9 to 2384.1
|
1575.1 titer
Interval 1051.1 to 2360.4
|
2056.3 titer
Interval 1471.1 to 2874.2
|
1391.3 titer
Interval 986.7 to 1961.7
|
1527.4 titer
Interval 1057.0 to 2207.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 29
|
12229.6 titer
Interval 9571.1 to 15626.7
|
9275.7 titer
Interval 6926.0 to 12422.7
|
10433.9 titer
Interval 7040.4 to 15463.1
|
7678.3 titer
Interval 6034.4 to 9770.0
|
8513.1 titer
Interval 6542.0 to 11078.0
|
10057.5 titer
Interval 7712.1 to 13116.1
|
8639.7 titer
Interval 7025.9 to 10624.1
|
7038.1 titer
Interval 5592.1 to 8858.0
|
10243.2 titer
Interval 8204.9 to 12787.7
|
9943.4 titer
Interval 7910.9 to 12498.1
|
7431.1 titer
Interval 6091.6 to 9065.1
|
—
|
—
|
—
|
—
|
—
|
7127.4 titer
Interval 5855.8 to 8675.1
|
6525.4 titer
Interval 4850.0 to 8779.4
|
6738.9 titer
Interval 5281.8 to 8597.8
|
7844.9 titer
Interval 6467.6 to 9515.4
|
7333.0 titer
Interval 5842.7 to 9203.4
|
6877.4 titer
Interval 5218.1 to 9064.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 181
|
5778.1 titer
Interval 4110.6 to 8121.9
|
4006.2 titer
Interval 2759.3 to 5816.7
|
3927.0 titer
Interval 2086.7 to 7390.1
|
3317.4 titer
Interval 2397.5 to 4590.2
|
3877.3 titer
Interval 2667.2 to 5636.2
|
5622.0 titer
Interval 3718.2 to 8500.5
|
3889.4 titer
Interval 2807.8 to 5387.6
|
3296.0 titer
Interval 2452.4 to 4429.8
|
4324.3 titer
Interval 3256.8 to 5741.6
|
3583.2 titer
Interval 2756.2 to 4658.4
|
3292.4 titer
Interval 2601.5 to 4166.7
|
—
|
—
|
—
|
—
|
—
|
3008.6 titer
Interval 2336.9 to 3873.5
|
2633.9 titer
Interval 1532.5 to 4527.0
|
2743.1 titer
Interval 1976.1 to 3807.9
|
2904.4 titer
Interval 2145.9 to 3931.1
|
1908.1 titer
Interval 1316.1 to 2766.3
|
2386.0 titer
Interval 1676.1 to 3396.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 10 and ULOQ = 640 for Influenza A H1N1 and Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 320 for Influenza B/Victoria, and LLOQ = 10 and ULOQ = 640 for Influenza B/Yamagata antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=49 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=45 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=47 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=53 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=36 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=52 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=51 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 29
|
1.8 ratio
Interval 1.5 to 2.2
|
2.0 ratio
Interval 1.7 to 2.3
|
2.7 ratio
Interval 2.0 to 3.6
|
1.6 ratio
Interval 1.4 to 2.0
|
2.5 ratio
Interval 1.8 to 3.6
|
1.9 ratio
Interval 1.5 to 2.4
|
2.6 ratio
Interval 2.1 to 3.4
|
2.1 ratio
Interval 1.6 to 2.8
|
2.2 ratio
Interval 1.7 to 2.9
|
1.6 ratio
Interval 1.2 to 2.0
|
2.4 ratio
Interval 1.8 to 3.2
|
—
|
—
|
—
|
—
|
—
|
2.4 ratio
Interval 1.8 to 3.0
|
2.8 ratio
Interval 2.1 to 3.9
|
2.4 ratio
Interval 1.8 to 3.3
|
2.1 ratio
Interval 1.6 to 2.7
|
2.3 ratio
Interval 1.8 to 3.0
|
3.4 ratio
Interval 2.5 to 4.5
|
2.4 ratio
Interval 1.8 to 3.3
|
2.6 ratio
Interval 1.7 to 3.8
|
2.6 ratio
Interval 2.0 to 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 181
|
1.8 ratio
Interval 1.1 to 3.0
|
1.3 ratio
Interval 0.8 to 2.2
|
2.0 ratio
Interval 1.3 to 3.0
|
1.3 ratio
Interval 1.0 to 1.6
|
1.7 ratio
Interval 1.0 to 2.9
|
1.2 ratio
Interval 0.9 to 1.7
|
1.6 ratio
Interval 1.0 to 2.7
|
2.0 ratio
Interval 1.3 to 3.3
|
1.4 ratio
Interval 1.0 to 1.9
|
1.9 ratio
Interval 1.3 to 2.7
|
1.1 ratio
Interval 0.8 to 1.4
|
—
|
—
|
—
|
—
|
—
|
0.9 ratio
Interval 0.7 to 1.3
|
1.4 ratio
Interval 1.0 to 1.9
|
1.3 ratio
Interval 0.9 to 1.8
|
1.4 ratio
Interval 1.0 to 1.9
|
0.9 ratio
Interval 0.7 to 1.3
|
1.5 ratio
Interval 1.1 to 2.1
|
1.1 ratio
Interval 0.8 to 1.6
|
1.2 ratio
Interval 0.9 to 1.8
|
1.1 ratio
Interval 0.8 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 29
|
1.9 ratio
Interval 1.5 to 2.6
|
1.6 ratio
Interval 1.3 to 1.9
|
2.0 ratio
Interval 1.6 to 2.6
|
1.4 ratio
Interval 1.2 to 1.6
|
1.6 ratio
Interval 1.2 to 2.1
|
1.5 ratio
Interval 1.2 to 1.8
|
1.8 ratio
Interval 1.5 to 2.2
|
1.7 ratio
Interval 1.2 to 2.2
|
1.6 ratio
Interval 1.3 to 1.9
|
1.5 ratio
Interval 1.2 to 1.9
|
1.9 ratio
Interval 1.5 to 2.5
|
—
|
—
|
—
|
—
|
—
|
1.8 ratio
Interval 1.5 to 2.1
|
2.1 ratio
Interval 1.6 to 2.7
|
1.9 ratio
Interval 1.5 to 2.4
|
2.0 ratio
Interval 1.6 to 2.6
|
1.8 ratio
Interval 1.4 to 2.2
|
2.1 ratio
Interval 1.7 to 2.6
|
2.1 ratio
Interval 1.8 to 2.4
|
2.4 ratio
Interval 1.8 to 3.3
|
1.9 ratio
Interval 1.5 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 181
|
1.8 ratio
Interval 1.3 to 2.4
|
1.8 ratio
Interval 1.4 to 2.2
|
2.6 ratio
Interval 1.6 to 4.2
|
1.9 ratio
Interval 1.5 to 2.3
|
3.6 ratio
Interval 2.6 to 5.0
|
2.4 ratio
Interval 1.8 to 3.2
|
2.7 ratio
Interval 2.0 to 3.7
|
2.6 ratio
Interval 1.9 to 3.7
|
2.4 ratio
Interval 1.9 to 3.2
|
2.1 ratio
Interval 1.6 to 2.8
|
2.5 ratio
Interval 1.8 to 3.4
|
—
|
—
|
—
|
—
|
—
|
2.4 ratio
Interval 1.9 to 3.1
|
3.2 ratio
Interval 2.6 to 4.1
|
3.0 ratio
Interval 2.2 to 4.1
|
2.3 ratio
Interval 1.8 to 3.1
|
3.0 ratio
Interval 2.1 to 4.3
|
3.3 ratio
Interval 2.5 to 4.3
|
2.3 ratio
Interval 1.7 to 3.1
|
2.3 ratio
Interval 1.6 to 3.3
|
2.7 ratio
Interval 2.0 to 3.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 29
|
2.0 ratio
Interval 1.6 to 2.5
|
2.3 ratio
Interval 1.8 to 2.8
|
3.7 ratio
Interval 2.8 to 4.8
|
2.1 ratio
Interval 1.7 to 2.6
|
3.8 ratio
Interval 2.5 to 5.6
|
2.2 ratio
Interval 1.8 to 2.8
|
2.8 ratio
Interval 2.1 to 3.6
|
2.4 ratio
Interval 1.7 to 3.4
|
3.1 ratio
Interval 2.4 to 3.9
|
1.8 ratio
Interval 1.4 to 2.3
|
2.3 ratio
Interval 1.8 to 3.0
|
—
|
—
|
—
|
—
|
—
|
2.3 ratio
Interval 1.8 to 2.9
|
2.7 ratio
Interval 2.1 to 3.5
|
2.7 ratio
Interval 2.0 to 3.7
|
2.4 ratio
Interval 1.8 to 3.3
|
2.9 ratio
Interval 2.2 to 3.8
|
3.6 ratio
Interval 2.6 to 5.0
|
2.5 ratio
Interval 1.8 to 3.5
|
2.7 ratio
Interval 1.9 to 3.8
|
3.3 ratio
Interval 2.6 to 4.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 181
|
2.2 ratio
Interval 1.6 to 2.9
|
3.2 ratio
Interval 2.4 to 4.2
|
4.6 ratio
Interval 3.1 to 6.8
|
2.9 ratio
Interval 2.3 to 3.5
|
5.7 ratio
Interval 3.4 to 9.5
|
3.2 ratio
Interval 2.4 to 4.4
|
3.2 ratio
Interval 2.3 to 4.3
|
2.7 ratio
Interval 1.9 to 3.9
|
3.9 ratio
Interval 3.0 to 5.0
|
2.5 ratio
Interval 1.8 to 3.4
|
3.0 ratio
Interval 2.3 to 3.9
|
—
|
—
|
—
|
—
|
—
|
2.6 ratio
Interval 1.9 to 3.4
|
3.2 ratio
Interval 2.3 to 4.5
|
3.5 ratio
Interval 2.5 to 4.8
|
3.5 ratio
Interval 2.4 to 5.0
|
4.3 ratio
Interval 2.9 to 6.4
|
3.8 ratio
Interval 2.6 to 5.8
|
3.2 ratio
Interval 2.3 to 4.3
|
3.3 ratio
Interval 2.4 to 4.4
|
3.9 ratio
Interval 2.8 to 5.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 29
|
2.2 ratio
Interval 1.6 to 2.9
|
1.9 ratio
Interval 1.5 to 2.4
|
3.3 ratio
Interval 2.4 to 4.6
|
1.9 ratio
Interval 1.6 to 2.4
|
2.5 ratio
Interval 1.6 to 3.7
|
2.0 ratio
Interval 1.7 to 2.4
|
2.9 ratio
Interval 2.2 to 3.8
|
3.3 ratio
Interval 2.3 to 4.7
|
2.5 ratio
Interval 1.9 to 3.3
|
1.8 ratio
Interval 1.3 to 2.5
|
2.4 ratio
Interval 1.8 to 3.2
|
—
|
—
|
—
|
—
|
—
|
1.9 ratio
Interval 1.5 to 2.3
|
2.7 ratio
Interval 2.1 to 3.4
|
2.1 ratio
Interval 1.8 to 2.5
|
2.5 ratio
Interval 1.8 to 3.4
|
2.6 ratio
Interval 1.9 to 3.6
|
2.2 ratio
Interval 1.7 to 2.8
|
3.1 ratio
Interval 2.4 to 3.9
|
2.7 ratio
Interval 2.0 to 3.8
|
2.4 ratio
Interval 1.9 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 181
|
2.4 ratio
Interval 1.7 to 3.4
|
2.1 ratio
Interval 1.7 to 2.7
|
2.9 ratio
Interval 2.0 to 4.3
|
1.9 ratio
Interval 1.5 to 2.3
|
3.2 ratio
Interval 2.1 to 5.0
|
2.3 ratio
Interval 1.8 to 2.8
|
2.4 ratio
Interval 1.7 to 3.4
|
4.0 ratio
Interval 2.7 to 5.8
|
2.9 ratio
Interval 2.2 to 3.9
|
2.9 ratio
Interval 2.1 to 4.0
|
3.1 ratio
Interval 2.3 to 4.2
|
—
|
—
|
—
|
—
|
—
|
2.2 ratio
Interval 1.6 to 2.9
|
3.4 ratio
Interval 2.6 to 4.6
|
3.1 ratio
Interval 2.3 to 4.0
|
3.6 ratio
Interval 2.7 to 4.7
|
3.0 ratio
Interval 1.8 to 5.0
|
2.5 ratio
Interval 1.8 to 3.4
|
2.6 ratio
Interval 2.1 to 3.2
|
3.1 ratio
Interval 2.0 to 4.6
|
2.9 ratio
Interval 2.1 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Antibody values reported as below LLOQ were replaced by 0.5 \* LLOQ. Values greater than ULOQ were converted to ULOQ. LLOQ = 53 and ULOQ = 71376 for SARS-CoV-2 BA.4/5 antibody and LLOQ = 74.1 and ULOQ = 184317 for SARS-CoV-2 D614G antibody. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=49 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=52 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=36 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=38 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 29
|
10.0 ratio
Interval 7.0 to 14.2
|
7.5 ratio
Interval 5.0 to 11.2
|
9.6 ratio
Interval 6.5 to 14.4
|
5.7 ratio
Interval 4.1 to 7.9
|
6.8 ratio
Interval 4.8 to 9.7
|
5.6 ratio
Interval 3.7 to 8.5
|
4.7 ratio
Interval 3.3 to 6.7
|
6.9 ratio
Interval 4.7 to 10.0
|
10.9 ratio
Interval 7.5 to 15.9
|
7.3 ratio
Interval 5.0 to 10.9
|
6.1 ratio
Interval 4.2 to 9.0
|
—
|
—
|
—
|
—
|
—
|
6.9 ratio
Interval 5.1 to 9.5
|
7.4 ratio
Interval 4.9 to 11.1
|
7.3 ratio
Interval 5.1 to 10.5
|
8.4 ratio
Interval 5.9 to 11.8
|
10.3 ratio
Interval 6.7 to 16.0
|
6.9 ratio
Interval 4.6 to 10.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 181
|
4.1 ratio
Interval 2.7 to 6.3
|
3.2 ratio
Interval 2.1 to 5.0
|
4.4 ratio
Interval 2.3 to 8.4
|
2.6 ratio
Interval 1.8 to 3.8
|
2.4 ratio
Interval 1.6 to 3.8
|
1.9 ratio
Interval 1.1 to 3.2
|
1.7 ratio
Interval 1.1 to 2.5
|
3.5 ratio
Interval 2.2 to 5.5
|
4.4 ratio
Interval 3.1 to 6.4
|
2.5 ratio
Interval 1.7 to 3.6
|
2.8 ratio
Interval 1.9 to 4.1
|
—
|
—
|
—
|
—
|
—
|
2.7 ratio
Interval 1.9 to 3.9
|
2.7 ratio
Interval 1.5 to 4.6
|
3.1 ratio
Interval 2.1 to 4.6
|
3.5 ratio
Interval 2.4 to 5.0
|
3.6 ratio
Interval 2.4 to 5.3
|
2.9 ratio
Interval 2.0 to 4.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 29
|
5.6 ratio
Interval 4.1 to 7.7
|
4.2 ratio
Interval 2.9 to 6.0
|
4.0 ratio
Interval 2.9 to 5.6
|
2.5 ratio
Interval 1.9 to 3.4
|
4.1 ratio
Interval 2.9 to 5.7
|
3.1 ratio
Interval 2.2 to 4.2
|
3.0 ratio
Interval 2.4 to 3.7
|
4.5 ratio
Interval 3.4 to 6.2
|
5.8 ratio
Interval 4.0 to 8.5
|
4.8 ratio
Interval 3.6 to 6.5
|
3.2 ratio
Interval 2.4 to 4.2
|
—
|
—
|
—
|
—
|
—
|
3.6 ratio
Interval 2.7 to 4.7
|
4.2 ratio
Interval 3.1 to 5.7
|
4.3 ratio
Interval 3.1 to 5.9
|
3.8 ratio
Interval 2.9 to 5.1
|
5.3 ratio
Interval 3.8 to 7.3
|
4.5 ratio
Interval 3.2 to 6.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 181
|
2.5 ratio
Interval 1.7 to 3.8
|
1.7 ratio
Interval 1.1 to 2.4
|
1.6 ratio
Interval 1.0 to 2.8
|
1.2 ratio
Interval 0.9 to 1.6
|
1.7 ratio
Interval 1.2 to 2.4
|
1.6 ratio
Interval 1.1 to 2.4
|
1.4 ratio
Interval 1.1 to 1.7
|
2.0 ratio
Interval 1.3 to 2.9
|
2.5 ratio
Interval 1.8 to 3.5
|
1.7 ratio
Interval 1.3 to 2.3
|
1.5 ratio
Interval 1.2 to 1.8
|
—
|
—
|
—
|
—
|
—
|
1.5 ratio
Interval 1.1 to 2.1
|
1.4 ratio
Interval 1.1 to 1.9
|
1.7 ratio
Interval 1.3 to 2.3
|
1.4 ratio
Interval 1.0 to 1.9
|
1.5 ratio
Interval 1.2 to 2.0
|
1.7 ratio
Interval 1.2 to 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29, and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \< 1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post vaccination HAI antibody titer. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=49 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=45 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=47 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=53 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=36 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=52 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=37 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=51 Participants
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 181
|
16.7 percentage of participants
Interval 6.4 to 32.8
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
30.6 percentage of participants
Interval 16.3 to 48.1
|
23.3 percentage of participants
Interval 11.8 to 38.6
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
27.3 percentage of participants
Interval 15.0 to 42.8
|
32.4 percentage of participants
Interval 18.0 to 49.8
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
21.4 percentage of participants
Interval 10.3 to 36.8
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
31.1 percentage of participants
Interval 18.2 to 46.6
|
—
|
—
|
—
|
—
|
—
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
40.9 percentage of participants
Interval 26.3 to 56.8
|
40.9 percentage of participants
Interval 26.3 to 56.8
|
38.6 percentage of participants
Interval 24.4 to 54.5
|
36.0 percentage of participants
Interval 18.0 to 57.5
|
44.2 percentage of participants
Interval 29.1 to 60.1
|
29.2 percentage of participants
Interval 17.0 to 44.1
|
29.6 percentage of participants
Interval 13.8 to 50.2
|
37.8 percentage of participants
Interval 23.8 to 53.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 181
|
25.0 percentage of participants
Interval 12.1 to 42.2
|
45.2 percentage of participants
Interval 27.3 to 64.0
|
61.1 percentage of participants
Interval 43.5 to 76.9
|
39.5 percentage of participants
Interval 25.0 to 55.6
|
63.6 percentage of participants
Interval 40.7 to 82.8
|
43.2 percentage of participants
Interval 28.3 to 59.0
|
50.0 percentage of participants
Interval 33.4 to 66.6
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
51.2 percentage of participants
Interval 35.1 to 67.1
|
33.3 percentage of participants
Interval 19.1 to 50.2
|
44.4 percentage of participants
Interval 29.6 to 60.0
|
—
|
—
|
—
|
—
|
—
|
30.8 percentage of participants
Interval 17.0 to 47.6
|
47.7 percentage of participants
Interval 32.5 to 63.3
|
38.6 percentage of participants
Interval 24.4 to 54.5
|
38.6 percentage of participants
Interval 24.4 to 54.5
|
44.0 percentage of participants
Interval 24.4 to 65.1
|
46.5 percentage of participants
Interval 31.2 to 62.3
|
52.1 percentage of participants
Interval 37.2 to 66.7
|
40.7 percentage of participants
Interval 22.4 to 61.2
|
52.3 percentage of participants
Interval 36.7 to 67.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 29
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
22.4 percentage of participants
Interval 11.8 to 36.6
|
48.8 percentage of participants
Interval 33.3 to 64.5
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
23.3 percentage of participants
Interval 9.9 to 42.3
|
24.5 percentage of participants
Interval 13.8 to 38.3
|
36.2 percentage of participants
Interval 22.7 to 51.5
|
41.9 percentage of participants
Interval 24.5 to 60.9
|
28.0 percentage of participants
Interval 16.2 to 42.5
|
21.6 percentage of participants
Interval 11.3 to 35.3
|
34.0 percentage of participants
Interval 21.2 to 48.8
|
—
|
—
|
—
|
—
|
—
|
13.0 percentage of participants
Interval 4.9 to 26.3
|
38.5 percentage of participants
Interval 25.3 to 53.0
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
34.0 percentage of participants
Interval 21.5 to 48.3
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
28.0 percentage of participants
Interval 16.2 to 42.5
|
38.5 percentage of participants
Interval 25.3 to 53.0
|
38.9 percentage of participants
Interval 23.1 to 56.5
|
28.0 percentage of participants
Interval 16.2 to 42.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 181
|
27.8 percentage of participants
Interval 14.2 to 45.2
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
37.1 percentage of participants
Interval 21.5 to 55.1
|
18.6 percentage of participants
Interval 8.4 to 33.4
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
20.5 percentage of participants
Interval 9.8 to 35.3
|
32.4 percentage of participants
Interval 18.0 to 49.8
|
60.0 percentage of participants
Interval 38.7 to 78.9
|
33.3 percentage of participants
Interval 19.6 to 49.5
|
35.9 percentage of participants
Interval 21.2 to 52.8
|
48.9 percentage of participants
Interval 33.7 to 64.2
|
—
|
—
|
—
|
—
|
—
|
31.6 percentage of participants
Interval 17.5 to 48.7
|
43.2 percentage of participants
Interval 28.3 to 59.0
|
47.7 percentage of participants
Interval 32.5 to 63.3
|
45.5 percentage of participants
Interval 30.4 to 61.2
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
32.6 percentage of participants
Interval 19.1 to 48.5
|
35.4 percentage of participants
Interval 22.2 to 50.5
|
48.1 percentage of participants
Interval 28.7 to 68.1
|
45.5 percentage of participants
Interval 30.4 to 61.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 181
|
33.3 percentage of participants
Interval 18.6 to 51.0
|
19.4 percentage of participants
Interval 7.5 to 37.5
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
9.3 percentage of participants
Interval 2.6 to 22.1
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
15.9 percentage of participants
Interval 6.6 to 30.1
|
23.7 percentage of participants
Interval 11.4 to 40.2
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
19.0 percentage of participants
Interval 8.6 to 34.1
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
8.9 percentage of participants
Interval 2.5 to 21.2
|
—
|
—
|
—
|
—
|
—
|
12.8 percentage of participants
Interval 4.3 to 27.4
|
18.2 percentage of participants
Interval 8.2 to 32.7
|
20.9 percentage of participants
Interval 10.0 to 36.0
|
15.9 percentage of participants
Interval 6.6 to 30.1
|
0 percentage of participants
Interval 0.0 to 13.7
|
16.3 percentage of participants
Interval 6.8 to 30.7
|
14.6 percentage of participants
Interval 6.1 to 27.8
|
14.8 percentage of participants
Interval 4.2 to 33.7
|
11.4 percentage of participants
Interval 3.8 to 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 29
|
14.0 percentage of participants
Interval 5.8 to 26.7
|
18.4 percentage of participants
Interval 8.8 to 32.0
|
28.9 percentage of participants
Interval 16.4 to 44.3
|
12.0 percentage of participants
Interval 4.5 to 24.3
|
33.3 percentage of participants
Interval 17.3 to 52.8
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
34.0 percentage of participants
Interval 20.9 to 49.3
|
19.4 percentage of participants
Interval 7.5 to 37.5
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
11.8 percentage of participants
Interval 4.4 to 23.9
|
30.0 percentage of participants
Interval 17.9 to 44.6
|
—
|
—
|
—
|
—
|
—
|
27.7 percentage of participants
Interval 15.6 to 42.6
|
36.5 percentage of participants
Interval 23.6 to 51.0
|
30.0 percentage of participants
Interval 17.9 to 44.6
|
20.8 percentage of participants
Interval 10.8 to 34.1
|
19.4 percentage of participants
Interval 8.2 to 36.0
|
48.0 percentage of participants
Interval 33.7 to 62.6
|
30.8 percentage of participants
Interval 18.7 to 45.1
|
29.7 percentage of participants
Interval 15.9 to 47.0
|
37.3 percentage of participants
Interval 24.1 to 51.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 29
|
22.0 percentage of participants
Interval 11.5 to 36.0
|
22.4 percentage of participants
Interval 11.8 to 36.6
|
55.6 percentage of participants
Interval 40.0 to 70.4
|
26.0 percentage of participants
Interval 14.6 to 40.3
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
22.6 percentage of participants
Interval 12.3 to 36.2
|
38.0 percentage of participants
Interval 24.7 to 52.8
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
44.9 percentage of participants
Interval 30.7 to 59.8
|
15.7 percentage of participants
Interval 7.0 to 28.6
|
32.0 percentage of participants
Interval 19.5 to 46.7
|
—
|
—
|
—
|
—
|
—
|
31.9 percentage of participants
Interval 19.1 to 47.1
|
40.4 percentage of participants
Interval 27.0 to 54.9
|
34.0 percentage of participants
Interval 21.2 to 48.8
|
24.5 percentage of participants
Interval 13.8 to 38.3
|
44.4 percentage of participants
Interval 27.9 to 61.9
|
44.0 percentage of participants
Interval 30.0 to 58.7
|
38.5 percentage of participants
Interval 25.3 to 53.0
|
35.1 percentage of participants
Interval 20.2 to 52.5
|
34.0 percentage of participants
Interval 21.2 to 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 29
|
18.0 percentage of participants
Interval 8.6 to 31.4
|
12.2 percentage of participants
Interval 4.6 to 24.8
|
28.9 percentage of participants
Interval 16.4 to 44.3
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
7.5 percentage of participants
Interval 2.1 to 18.2
|
16.7 percentage of participants
Interval 7.5 to 30.2
|
16.1 percentage of participants
Interval 5.5 to 33.7
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
9.8 percentage of participants
Interval 3.3 to 21.4
|
24.0 percentage of participants
Interval 13.1 to 38.2
|
—
|
—
|
—
|
—
|
—
|
12.8 percentage of participants
Interval 4.8 to 25.7
|
23.1 percentage of participants
Interval 12.5 to 36.8
|
20.0 percentage of participants
Interval 10.0 to 33.7
|
21.2 percentage of participants
Interval 11.1 to 34.7
|
19.4 percentage of participants
Interval 8.2 to 36.0
|
20.0 percentage of participants
Interval 10.0 to 33.7
|
17.3 percentage of participants
Interval 8.2 to 30.3
|
32.4 percentage of participants
Interval 18.0 to 49.8
|
16.0 percentage of participants
Interval 7.2 to 29.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 29, and Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category. Arms based on the applicable vaccine for this Outcome Measure.
SARS-CoV-2 strain included BA.4/5 and D614G antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 x LLOQ if baseline nAb level was \<LLOQ, or ≥4 fold rise if baseline nAb level was ≥LLOQ. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=49 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=52 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=31 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=50 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=53 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=51 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=51 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 Participants
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=36 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=50 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=52 Participants
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=38 Participants
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=50 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 181
|
44.7 percentage of participants
Interval 28.6 to 61.7
|
41.9 percentage of participants
Interval 27.0 to 57.9
|
50.0 percentage of participants
Interval 28.2 to 71.8
|
41.9 percentage of participants
Interval 27.0 to 57.9
|
28.2 percentage of participants
Interval 15.0 to 44.9
|
20.0 percentage of participants
Interval 6.8 to 40.7
|
16.7 percentage of participants
Interval 7.0 to 31.4
|
40.9 percentage of participants
Interval 26.3 to 56.8
|
53.2 percentage of participants
Interval 38.1 to 67.9
|
37.8 percentage of participants
Interval 23.8 to 53.5
|
29.5 percentage of participants
Interval 16.8 to 45.2
|
—
|
—
|
—
|
—
|
—
|
31.8 percentage of participants
Interval 18.6 to 47.6
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
34.9 percentage of participants
Interval 21.0 to 50.9
|
39.6 percentage of participants
Interval 25.8 to 54.7
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
35.6 percentage of participants
Interval 21.9 to 51.2
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 29
|
57.1 percentage of participants
Interval 42.2 to 71.2
|
37.5 percentage of participants
Interval 24.0 to 52.6
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
21.2 percentage of participants
Interval 11.1 to 34.7
|
43.1 percentage of participants
Interval 29.3 to 57.8
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
32.0 percentage of participants
Interval 19.5 to 46.7
|
42.0 percentage of participants
Interval 28.2 to 56.8
|
50.9 percentage of participants
Interval 36.8 to 64.9
|
43.1 percentage of participants
Interval 29.3 to 57.8
|
33.3 percentage of participants
Interval 20.8 to 47.9
|
—
|
—
|
—
|
—
|
—
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
41.7 percentage of participants
Interval 25.5 to 59.2
|
42.0 percentage of participants
Interval 28.2 to 56.8
|
48.1 percentage of participants
Interval 34.0 to 62.4
|
57.9 percentage of participants
Interval 40.8 to 73.7
|
42.0 percentage of participants
Interval 28.2 to 56.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 BA.4/5 Antibody: Day 29
|
69.4 percentage of participants
Interval 54.6 to 81.7
|
68.0 percentage of participants
Interval 53.3 to 80.5
|
75.9 percentage of participants
Interval 56.5 to 89.7
|
56.9 percentage of participants
Interval 45.1 to 73.0
|
62.7 percentage of participants
Interval 48.1 to 75.9
|
58.1 percentage of participants
Interval 39.1 to 75.5
|
44.0 percentage of participants
Interval 30.0 to 58.7
|
60.0 percentage of participants
Interval 45.2 to 73.6
|
76.5 percentage of participants
Interval 62.5 to 87.2
|
62.7 percentage of participants
Interval 48.1 to 75.9
|
51.0 percentage of participants
Interval 36.6 to 65.2
|
—
|
—
|
—
|
—
|
—
|
62.3 percentage of participants
Interval 47.9 to 75.5
|
58.3 percentage of participants
Interval 40.8 to 74.5
|
60.0 percentage of participants
Interval 45.2 to 73.6
|
65.4 percentage of participants
Interval 50.9 to 78.0
|
68.4 percentage of participants
Interval 51.3 to 82.5
|
68.0 percentage of participants
Interval 53.3 to 80.5
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 1: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
SARS-CoV-2 D614G Antibody: Day 181
|
31.6 percentage of participants
Interval 17.5 to 48.7
|
18.6 percentage of participants
Interval 8.4 to 33.4
|
18.2 percentage of participants
Interval 5.2 to 40.3
|
7.0 percentage of participants
Interval 1.5 to 19.1
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
7.1 percentage of participants
Interval 1.5 to 19.5
|
22.7 percentage of participants
Interval 11.5 to 37.8
|
34.0 percentage of participants
Interval 20.9 to 49.3
|
17.8 percentage of participants
Interval 8.0 to 32.1
|
9.1 percentage of participants
Interval 2.5 to 21.7
|
—
|
—
|
—
|
—
|
—
|
11.4 percentage of participants
Interval 3.8 to 24.6
|
8.0 percentage of participants
Interval 1.0 to 26.0
|
23.3 percentage of participants
Interval 11.8 to 38.6
|
12.5 percentage of participants
Interval 4.7 to 25.2
|
3.6 percentage of participants
Interval 0.1 to 18.3
|
15.9 percentage of participants
Interval 6.6 to 30.1
|
—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Baseline (Day 1), Day 181Population: PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 'Number analyzed' = participants evaluable for specified category.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=37 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=38 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 181
|
91.3 titer
Interval 65.4 to 127.6
|
108.4 titer
Interval 74.6 to 157.5
|
95.1 titer
Interval 65.9 to 137.1
|
93.1 titer
Interval 63.1 to 137.4
|
119.9 titer
Interval 87.7 to 163.9
|
111.9 titer
Interval 72.1 to 173.6
|
76.4 titer
Interval 52.4 to 111.4
|
108.4 titer
Interval 78.2 to 150.2
|
82.8 titer
Interval 60.6 to 113.2
|
81.6 titer
Interval 57.6 to 115.8
|
101.5 titer
Interval 73.1 to 141.1
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 1
|
41.0 titer
Interval 31.7 to 53.0
|
60.4 titer
Interval 49.9 to 73.1
|
52.6 titer
Interval 40.7 to 68.0
|
64.6 titer
Interval 49.0 to 85.0
|
62.3 titer
Interval 49.1 to 79.0
|
50.8 titer
Interval 39.0 to 66.2
|
66.1 titer
Interval 49.1 to 89.0
|
53.6 titer
Interval 41.1 to 69.8
|
49.3 titer
Interval 38.3 to 63.5
|
49.8 titer
Interval 38.6 to 64.2
|
48.7 titer
Interval 37.4 to 63.5
|
—
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—
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—
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—
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—
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—
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—
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|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody: Day 1
|
30.1 titer
Interval 20.7 to 43.9
|
35.1 titer
Interval 24.0 to 51.3
|
41.8 titer
Interval 31.5 to 64.1
|
44.9 titer
Interval 31.5 to 64.1
|
40.6 titer
Interval 29.6 to 55.7
|
49.9 titer
Interval 33.3 to 74.8
|
45.5 titer
Interval 32.6 to 63.5
|
32.7 titer
Interval 22.9 to 46.8
|
31.4 titer
Interval 21.0 to 46.9
|
30.4 titer
Interval 20.3 to 45.4
|
37.1 titer
Interval 26.7 to 51.6
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 1
|
36.5 titer
Interval 24.3 to 54.7
|
46.0 titer
Interval 31.9 to 66.3
|
37.2 titer
Interval 27.8 to 49.8
|
36.8 titer
Interval 28.1 to 48.3
|
46.4 titer
Interval 33.2 to 64.8
|
39.6 titer
Interval 28.9 to 54.4
|
36.6 titer
Interval 26.8 to 50.0
|
35.2 titer
Interval 25.7 to 48.3
|
42.1 titer
Interval 30.5 to 58.3
|
28.8 titer
Interval 21.3 to 38.8
|
30.2 titer
Interval 22.9 to 39.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody: Day 181
|
65.2 titer
Interval 45.5 to 93.5
|
100.7 titer
Interval 72.9 to 139.2
|
64.1 titer
Interval 46.3 to 88.8
|
52.6 titer
Interval 38.2 to 72.5
|
89.8 titer
Interval 62.2 to 129.6
|
61.7 titer
Interval 43.7 to 87.0
|
49.3 titer
Interval 35.6 to 68.3
|
63.0 titer
Interval 45.5 to 87.3
|
82.9 titer
Interval 57.6 to 119.2
|
50.9 titer
Interval 37.1 to 69.8
|
52.4 titer
Interval 37.7 to 72.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody: Day 181
|
55.4 titer
Interval 42.4 to 72.5
|
64.9 titer
Interval 47.9 to 87.9
|
56.5 titer
Interval 43.0 to 74.3
|
73.0 titer
Interval 54.6 to 97.4
|
69.9 titer
Interval 51.9 to 94.0
|
71.0 titer
Interval 53.2 to 94.8
|
62.5 titer
Interval 46.7 to 83.7
|
56.0 titer
Interval 44.5 to 70.4
|
62.0 titer
Interval 48.4 to 79.4
|
54.2 titer
Interval 39.7 to 74.1
|
56.6 titer
Interval 44.8 to 71.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 1
|
54.5 titer
Interval 40.8 to 72.9
|
84.7 titer
Interval 63.7 to 112.6
|
63.0 titer
Interval 47.2 to 83.9
|
70.1 titer
Interval 54.7 to 89.8
|
69.7 titer
Interval 53.6 to 90.5
|
69.4 titer
Interval 52.1 to 92.3
|
72.1 titer
Interval 53.8 to 96.6
|
73.6 titer
Interval 52.3 to 103.6
|
67.6 titer
Interval 49.9 to 91.5
|
80.8 titer
Interval 60.1 to 108.5
|
63.0 titer
Interval 49.6 to 80.0
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: GMT of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody: Day 181
|
92.3 titer
Interval 71.4 to 119.2
|
108.5 titer
Interval 78.7 to 149.4
|
68.5 titer
Interval 50.7 to 92.7
|
70.8 titer
Interval 54.7 to 91.6
|
80.7 titer
Interval 60.9 to 107.0
|
82.6 titer
Interval 59.1 to 115.5
|
60.8 titer
Interval 45.1 to 82.1
|
73.3 titer
Interval 54.0 to 99.6
|
84.7 titer
Interval 63.4 to 113.3
|
110.8 titer
Interval 82.9 to 148.0
|
63.0 titer
Interval 46.1 to 86.1
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 181Population: PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response. 'Number analyzed' = participants evaluable for specified category.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=38 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=39 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 1
|
214.1 AU/mL
Interval 145.3 to 315.4
|
128.8 AU/mL
Interval 82.4 to 201.3
|
168.1 AU/mL
Interval 110.3 to 256.1
|
198.5 AU/mL
Interval 121.2 to 325.1
|
307.8 AU/mL
Interval 194.8 to 486.4
|
151.5 AU/mL
Interval 96.2 to 238.6
|
212.0 AU/mL
Interval 140.8 to 319.2
|
127.6 AU/mL
Interval 81.4 to 200.1
|
136.2 AU/mL
Interval 92.0 to 201.7
|
292.2 AU/mL
Interval 197.1 to 433.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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|
Part 2: GM Concentration of Antibodies for SARS-CoV-2, as Measured by PsVNA
SARS-CoV-2 Omicron XBB.1.5 Antibody: Day 181
|
998.7 AU/mL
Interval 640.6 to 1557.2
|
377.8 AU/mL
Interval 258.0 to 553.4
|
562.2 AU/mL
Interval 364.2 to 867.8
|
629.8 AU/mL
Interval 419.3 to 946.0
|
809.5 AU/mL
Interval 555.1 to 1180.3
|
349.0 AU/mL
Interval 225.7 to 539.8
|
642.9 AU/mL
Interval 445.3 to 928.2
|
682.7 AU/mL
Interval 429.1 to 1086.2
|
472 AU/mL
Interval 307.2 to 725.3
|
906.7 AU/mL
Interval 678.5 to 1211.6
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below LLOQ replaced by 0.5 \* LLOQ. Values greater than ULOQ converted to ULOQ. LLOQ= 10, ULOQ= 3620 for Influenza A H1N1, LLOQ= 10, ULOQ= 5120 for Influenza A H3N2, LLOQ= 10, ULOQ= 1356 for Influenza B/Victoria-lineage, and LLOQ= 10, ULOQ= 1280 for Influenza B/Yamagata-lineage. 95% CI was calculated based on t-distribution of log-transformed values for GMFR, then back transformed to original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=34 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=34 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=33 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
3.2 ratio
Interval 2.3 to 4.4
|
3.1 ratio
Interval 2.2 to 4.3
|
2.3 ratio
Interval 1.8 to 2.8
|
2.1 ratio
Interval 1.5 to 2.9
|
2.9 ratio
Interval 2.2 to 3.9
|
2.3 ratio
Interval 1.7 to 3.2
|
1.7 ratio
Interval 1.2 to 2.4
|
3.7 ratio
Interval 2.4 to 5.6
|
2.8 ratio
Interval 2.0 to 4.1
|
2.9 ratio
Interval 2.0 to 4.2
|
3.0 ratio
Interval 2.2 to 4.1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody
|
1.6 ratio
Interval 1.3 to 1.9
|
1.3 ratio
Interval 1.0 to 1.6
|
1.1 ratio
Interval 0.9 to 1.4
|
1.0 ratio
Interval 0.8 to 1.3
|
1.2 ratio
Interval 1.0 to 1.4
|
1.2 ratio
Interval 1.0 to 1.6
|
0.9 ratio
Interval 0.7 to 1.0
|
1.2 ratio
Interval 0.9 to 1.6
|
1.2 ratio
Interval 1.0 to 1.6
|
1.3 ratio
Interval 1.1 to 1.6
|
1.1 ratio
Interval 0.8 to 1.3
|
—
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—
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—
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—
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—
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—
|
|
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
1.9 ratio
Interval 1.5 to 2.6
|
2.1 ratio
Interval 1.5 to 2.8
|
1.7 ratio
Interval 1.3 to 2.2
|
1.4 ratio
Interval 1.0 to 1.8
|
2.0 ratio
Interval 1.6 to 2.6
|
1.4 ratio
Interval 1.0 to 2.0
|
1.4 ratio
Interval 1.1 to 1.7
|
2.0 ratio
Interval 1.6 to 2.6
|
1.8 ratio
Interval 1.4 to 2.5
|
2.0 ratio
Interval 1.5 to 2.6
|
1.8 ratio
Interval 1.4 to 2.5
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Part 2: GMFR of Antibodies for Influenza, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody
|
1.4 ratio
Interval 1.1 to 1.9
|
1.1 ratio
Interval 0.9 to 1.5
|
1.1 ratio
Interval 0.8 to 1.4
|
1.1 ratio
Interval 0.8 to 1.5
|
1.2 ratio
Interval 0.9 to 1.5
|
1.4 ratio
Interval 1.1 to 1.8
|
1.0 ratio
Interval 0.7 to 1.3
|
1.2 ratio
Interval 0.9 to 1.5
|
1.3 ratio
Interval 1.0 to 1.7
|
1.2 ratio
Interval 0.9 to 1.6
|
1.2 ratio
Interval 0.9 to 1.5
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. PP Set: all randomized participants who received study drug, complied with injection schedule, complied with timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=30 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=34 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=35 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=37 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
|
4.5 ratio
Interval 2.7 to 7.7
|
2.8 ratio
Interval 1.8 to 4.5
|
3.7 ratio
Interval 2.2 to 6.2
|
3.4 ratio
Interval 2.3 to 5.1
|
2.3 ratio
Interval 1.5 to 3.5
|
2.5 ratio
Interval 1.6 to 4.0
|
2.9 ratio
Interval 1.9 to 4.5
|
4.7 ratio
Interval 2.7 to 8.1
|
3.9 ratio
Interval 2.8 to 5.5
|
3.3 ratio
Interval 2.2 to 4.8
|
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=34 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=33 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=34 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=33 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Yamagata-lineage Antibody
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
6.1 percentage of participants
Interval 0.7 to 20.2
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
2.8 percentage of participants
Interval 0.1 to 14.5
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
2.6 percentage of participants
Interval 0.1 to 13.8
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
6.7 percentage of participants
Interval 0.8 to 20.8
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
0 percentage of participants
Interval 0.0 to 10.9
|
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Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H1N1 Antibody
|
50.0 percentage of participants
Interval 32.4 to 67.6
|
36.4 percentage of participants
Interval 20.4 to 54.9
|
22.2 percentage of participants
Interval 10.1 to 39.2
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
25.0 percentage of participants
Interval 11.5 to 43.4
|
26.3 percentage of participants
Interval 13.4 to 43.1
|
40.6 percentage of participants
Interval 23.7 to 59.4
|
40.0 percentage of participants
Interval 22.7 to 59.4
|
45.5 percentage of participants
Interval 28.1 to 63.6
|
43.8 percentage of participants
Interval 26.4 to 62.3
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Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza A H3N2 Antibody
|
29.4 percentage of participants
Interval 15.1 to 47.5
|
24.2 percentage of participants
Interval 11.1 to 42.3
|
19.4 percentage of participants
Interval 8.2 to 36.0
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
25.0 percentage of participants
Interval 12.1 to 42.2
|
15.6 percentage of participants
Interval 5.3 to 32.8
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
30.3 percentage of participants
Interval 15.6 to 48.7
|
28.1 percentage of participants
Interval 13.7 to 46.7
|
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Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
Influenza B/Victoria-lineage Antibody
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
9.1 percentage of participants
Interval 1.9 to 24.3
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
5.6 percentage of participants
Interval 0.7 to 18.7
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
10.5 percentage of participants
Interval 2.9 to 24.8
|
12.5 percentage of participants
Interval 3.5 to 29.0
|
10.0 percentage of participants
Interval 2.1 to 26.5
|
12.1 percentage of participants
Interval 3.4 to 28.2
|
6.3 percentage of participants
Interval 0.8 to 20.8
|
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SECONDARY outcome
Timeframe: Baseline (Day 1) to Day 181Population: PP Set. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. Arms based on the applicable vaccine for this Outcome Measure.
SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline nAb level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. PP Set included all randomized participants who received the study intervention, complied with the injection schedule, complied with the timings of immunogenicity blood sampling to have a Baseline and at least 1 post-injection assessment at Day 29, had no documented infection of either influenza or SARS-CoV-2 on Day 1 and up to Day 29, had no major dosing error, and had no major protocol deviations or conditions/medications that affected the immune response.
Outcome measures
| Measure |
Part 2: Investigational COVID-19 Vaccine 2
n=30 Participants
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=36 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=34 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=35 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=38 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=30 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=32 Participants
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: Influenza Vaccine 1
n=37 Participants
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
Part 2: COVID-19 Vaccine 2
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 1
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
|
43.3 percentage of participants
Interval 25.5 to 62.6
|
36.1 percentage of participants
Interval 20.8 to 53.8
|
32.4 percentage of participants
Interval 17.4 to 50.5
|
37.1 percentage of participants
Interval 21.5 to 55.1
|
25.0 percentage of participants
Interval 11.5 to 43.4
|
31.6 percentage of participants
Interval 17.5 to 48.7
|
28.1 percentage of participants
Interval 13.7 to 46.7
|
50.0 percentage of participants
Interval 31.3 to 68.7
|
50.0 percentage of participants
Interval 31.9 to 68.1
|
40.5 percentage of participants
Interval 24.8 to 57.9
|
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Adverse Events
Part 2: mRNA-1083 Composition 1 Dose Level 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 1 Dose Level 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 1 Dose Level 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 1 Dose Level 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 2 Dose Level 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 2 Dose Level 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 2 Dose Level 3
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 2: mRNA-1083 Composition 2 Dose Level 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: COVID-19 Vaccine 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Investigational COVID-19 Vaccine 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort A12: Influenza Vaccine 1
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort A13: Influenza Vaccine 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort A11: Investigational Influenza Vaccine 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 Cohort A8: Investigational Influenza Vaccine 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort A10: COVID-19 Vaccine 1
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort A7: mRNA-1083.3
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 Cohort B12: Influenza Vaccine 1
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort B11: Investigational Influenza Vaccine 2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 Cohort B8: Investigational Influenza Vaccine 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort B10: COVID-19 Vaccine 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 Cohort B7: mRNA-1083.3
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Influenza Vaccine 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 1 Cohort A12: Influenza Vaccine 1
n=54 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A13: Influenza Vaccine 2
n=53 participants at risk
Participants received a single IM injection of Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A11: Investigational Influenza Vaccine 2
n=54 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A8: Investigational Influenza Vaccine 1
n=51 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A10: COVID-19 Vaccine 1
n=54 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
n=52 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
n=51 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
n=33 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
n=55 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
n=53 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
n=33 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 participants at risk
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=56 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=55 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=56 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=54 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=54 participants at risk
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/52 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Sepsis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/39 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.0%
1/33 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Psychiatric disorders
Bipolar II disorder
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/52 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/39 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Eye disorders
Visual impairment
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/41 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Vascular disorders
Hypotension
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/41 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Coeliac artery compression syndrome
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/39 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/41 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/38 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Gastrointestinal disorders
Splenic artery aneurysm
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/41 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Renal and urinary disorders
Renal pseudoaneurysm
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.7%
1/37 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/39 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
Other adverse events
| Measure |
Part 2: mRNA-1083 Composition 1 Dose Level 1
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 2
n=42 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 3
n=41 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 1 Dose Level 4
n=41 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 1 at dose level 4 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 1
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 1 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 2
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 2 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 3
n=40 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 3 on Day 1.
|
Part 2: mRNA-1083 Composition 2 Dose Level 4
n=42 participants at risk
Participants received a single IM injection of mRNA-1083 Composition 2 at dose level 4 on Day 1.
|
Part 2: COVID-19 Vaccine 2
n=42 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 2 on Day 1.
|
Part 2: Investigational COVID-19 Vaccine 2
n=40 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.
|
Part 1 Cohort A12: Influenza Vaccine 1
n=54 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A13: Influenza Vaccine 2
n=53 participants at risk
Participants received a single IM injection of Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A11: Investigational Influenza Vaccine 2
n=54 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort A8: Investigational Influenza Vaccine 1
n=51 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort A10: COVID-19 Vaccine 1
n=54 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A9: Investigational COVID-19 Vaccine 1
n=52 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort A2: mRNA-1083.1 Dose Level 2
n=51 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort A3: mRNA-1083.1 Dose Level 3
n=33 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort A4: mRNA-1083.2 Dose Level 1
n=55 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort A5: mRNA-1083.2 Dose Level 2
n=53 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort A6: mRNA-1083.2 Dose Level 3
n=33 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort A7: mRNA-1083.3
n=53 participants at risk
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 1 Cohort B12: Influenza Vaccine 1
n=52 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B11: Investigational Influenza Vaccine 2
n=55 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 2 on Day 1.
|
Part 1 Cohort B8: Investigational Influenza Vaccine 1
n=55 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 on Day 1.
|
Part 1 Cohort B10: COVID-19 Vaccine 1
n=53 participants at risk
Participants received a single IM injection of COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B9: Investigational COVID-19 Vaccine 1
n=55 participants at risk
Participants received a single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.
|
Part 1 Cohort B1: mRNA-1083.1 Dose Level 1
n=56 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 1 on Day 1.
|
Part 1 Cohort B2: mRNA-1083.1 Dose Level 2
n=55 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 2 on Day 1.
|
Part 1 Cohort B3: mRNA-1083.1 Dose Level 3
n=37 participants at risk
Participants received a single IM injection of mRNA-1083.1 at dose level 3 on Day 1.
|
Part 1 Cohort B4: mRNA-1083.2 Dose Level 1
n=56 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 1 on Day 1.
|
Part 1 Cohort B5: mRNA-1083.2 Dose Level 2
n=54 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 2 on Day 1.
|
Part 1 Cohort B6: mRNA-1083.2 Dose Level 3
n=38 participants at risk
Participants received a single IM injection of mRNA-1083.2 at dose level 3 on Day 1.
|
Part 1 Cohort B7: mRNA-1083.3
n=54 participants at risk
Participants received a single IM injection of mRNA-1083.3 on Day 1.
|
Part 2: Influenza Vaccine 1
n=40 participants at risk
Participants received a single IM injection of Influenza Vaccine 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 1
n=39 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 1 on Day 1.
|
Part 2: Investigational Influenza Vaccine 1 Dose Level 2
n=40 participants at risk
Participants received a single IM injection of Investigational Influenza Vaccine 1 at dose level 2 on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
7.3%
3/41 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.0%
2/40 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.0%
2/40 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.8%
2/53 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.8%
3/52 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.7%
3/53 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.6%
2/55 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.6%
2/56 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.4%
2/37 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/56 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.3%
2/38 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
4.9%
2/41 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/41 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
7.5%
3/40 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.0%
2/40 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.4%
1/42 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.7%
2/54 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.8%
2/52 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.7%
3/53 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.8%
2/53 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.4%
3/56 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.7%
1/37 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.6%
2/56 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
11.1%
6/54 • Number of events 8 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/38 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.0%
2/40 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.5%
1/40 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 4 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.7%
2/54 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.8%
2/52 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
6.1%
2/33 • Number of events 3 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/52 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/53 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/55 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
3.6%
2/56 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.9%
1/54 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.6%
1/38 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/41 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/42 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
2.0%
1/51 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/51 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/33 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/52 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/53 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/55 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/37 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
1.8%
1/56 • Number of events 1 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
5.3%
2/38 • Number of events 2 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/54 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/39 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
0.00%
0/40 • All-cause mortality, SAEs, AESIs, MAAEs, and AEs leading to study discontinuation were collected up to Day 181. Other (non-serious) adverse events were collected from the time of injection through 28 days after the injection, unless they met the criteria for AESIs, MAAEs, or AEs led to study discontinuation.
The Safety Set included all randomized participants who received the study intervention. Participants were included in the vaccination group corresponding to what they actually received (as treated).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place