Trial Outcomes & Findings for A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants (NCT NCT04927065)
NCT ID: NCT04927065
Last Updated: 2025-02-28
Results Overview
Solicited ARs (local and systemic) were collected in 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. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. The Investigator reviewed whether the solicited AR was also to be recorded as an adverse event (AE). A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
5161 participants
Primary outcome timeframe
7 days post-vaccination
Results posted on
2025-02-28
Participant Flow
135 participants from Part A.1 rolled over to Part A.2. 87 participants from Part H rolled over to Part J. Therefore, a total number of enrolled and treated participants in the study = 5161.
Participant milestones
| Measure |
Part A.1: mRNA-1273.211 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (NCT04470427; COVE), received a single intramuscular (IM) booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the Emergency Use Authorization (EUA), received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Booster
STARTED
|
300
|
593
|
0
|
305
|
581
|
586
|
327
|
583
|
42
|
133
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Safety Set
|
300
|
593
|
0
|
305
|
581
|
586
|
327
|
583
|
42
|
133
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Solicited Safety Set
|
298
|
591
|
0
|
303
|
577
|
583
|
327
|
583
|
42
|
133
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Per-Protocol Immunogenicity SARS-CoV-2 Negative Set (PPIS-Neg)
|
295
|
563
|
0
|
245
|
489
|
547
|
250
|
509
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Per-Protocol Immunogenicity Set (PPIS)
|
299
|
576
|
0
|
257
|
537
|
569
|
314
|
543
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
COMPLETED
|
276
|
545
|
0
|
267
|
515
|
536
|
291
|
524
|
38
|
110
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
NOT COMPLETED
|
24
|
48
|
0
|
38
|
66
|
50
|
36
|
59
|
4
|
23
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Booster
STARTED
|
0
|
0
|
135
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
376
|
375
|
437
|
510
|
0
|
0
|
|
Second Booster
Safety Set
|
0
|
0
|
135
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
376
|
375
|
437
|
510
|
0
|
0
|
|
Second Booster
Solicited Safety Set
|
0
|
0
|
128
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
350
|
372
|
437
|
507
|
0
|
0
|
|
Second Booster
PPIS-Neg
|
0
|
0
|
76
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
258
|
273
|
334
|
209
|
0
|
0
|
|
Second Booster
PPIS
|
0
|
0
|
126
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
362
|
358
|
428
|
494
|
0
|
0
|
|
Second Booster
COMPLETED
|
0
|
0
|
128
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
356
|
345
|
405
|
482
|
0
|
0
|
|
Second Booster
NOT COMPLETED
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
20
|
30
|
32
|
28
|
0
|
0
|
|
Third Booster
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
50
|
50
|
|
Third Booster
Safety Set
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
50
|
50
|
|
Third Booster
Solicited Safety Set
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
50
|
50
|
|
Third Booster
PPIS-Neg
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
16
|
|
Third Booster
PPIS
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
49
|
49
|
|
Third Booster
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
50
|
48
|
|
Third Booster
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Part A.1: mRNA-1273.211 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (NCT04470427; COVE), received a single intramuscular (IM) booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the Emergency Use Authorization (EUA), received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
First Booster
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Death
|
1
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Lost to Follow-up
|
8
|
20
|
0
|
11
|
43
|
30
|
28
|
23
|
4
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Physician Decision
|
1
|
0
|
0
|
3
|
1
|
1
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Protocol Violation
|
4
|
4
|
0
|
3
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Withdrawal by Subject
|
8
|
23
|
0
|
19
|
20
|
15
|
6
|
24
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
First Booster
Other Than Specified
|
1
|
1
|
0
|
1
|
2
|
3
|
2
|
6
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Booster
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
2
|
0
|
0
|
|
Second Booster
Lost to Follow-up
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
10
|
13
|
16
|
0
|
0
|
|
Second Booster
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
1
|
0
|
0
|
|
Second Booster
Withdrawal by Subject
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
16
|
13
|
9
|
0
|
0
|
|
Second Booster
Other Than Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
4
|
0
|
0
|
0
|
|
Third Booster
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Third Booster
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
Baseline characteristics by cohort
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=300 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single intramuscular (IM) booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=593 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
n=135 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
n=305 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
n=581 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
n=586 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
n=327 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
n=583 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
n=42 Participants
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
n=133 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
n=376 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
n=375 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
n=437 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
n=510 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
Total
n=5383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
All Parts Excluding Part A.2 and Parts J · Female
|
167 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
330 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
131 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
313 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
287 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
204 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
284 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
23 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
70 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
190 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
173 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
258 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
316 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
2746 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
All Parts Excluding Part A.2 and Parts J · <=18 years
|
0 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
0 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
0 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
All Parts Excluding Part A.2 and Parts J · Between 18 and 65 years
|
238 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
447 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
216 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
466 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
467 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
292 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
426 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
41 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
115 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
226 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
254 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
263 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
405 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
3856 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
All Parts Excluding Part A.2 and Parts J · >=65 years
|
62 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
146 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
89 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
115 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
119 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
35 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
157 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
18 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
150 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
121 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
174 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
105 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
1292 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
Part A.2 and Parts J · <=18 years
|
—
|
—
|
0 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
Part A.2 and Parts J · Between 18 and 65 years
|
—
|
—
|
112 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
43 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
39 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
194 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Age, Categorical
Part A.2 and Parts J · >=65 years
|
—
|
—
|
23 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
11 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
41 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Sex: Female, Male
All Parts Excluding Part A.2 and Parts J · Male
|
133 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
263 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
174 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
268 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
299 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
123 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
299 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
19 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
63 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
186 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
202 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
179 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
194 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
2402 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Sex: Female, Male
Part A.2 and Parts J · Female
|
—
|
—
|
75 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
31 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
30 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
136 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Sex: Female, Male
Part A.2 and Parts J · Male
|
—
|
—
|
60 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
20 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
99 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Hispanic or Latino
|
38 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
51 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
66 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
100 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
106 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
32 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
68 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
17 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
37 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
47 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
46 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
58 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
667 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Not Hispanic or Latino
|
262 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
538 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
237 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
475 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
474 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
294 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
512 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
41 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
113 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
339 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
324 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
390 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
447 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
4446 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Unknown or Not Reported
|
0 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
2 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
6 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
6 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
5 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
35 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
Part A.2 and Parts J · Hispanic or Latino
|
—
|
—
|
15 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
9 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
30 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
Part A.2 and Parts J · Not Hispanic or Latino
|
—
|
—
|
120 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
43 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
40 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
203 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Ethnicity (NIH/OMB)
Part A.2 and Parts J · Unknown or Not Reported
|
—
|
—
|
0 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · American Indian or Alaska Native
|
1 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
5 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
0 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
5 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
22 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Asian
|
9 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
18 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
6 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
23 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
51 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
10 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
26 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
6 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
16 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
14 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
14 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
11 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
206 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
0 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
9 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Black or African American
|
19 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
34 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
17 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
54 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
32 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
23 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
49 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
26 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
28 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
21 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
31 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
56 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
391 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · White
|
257 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
518 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
279 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
473 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
481 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
282 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
478 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
38 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
97 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
322 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
325 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
381 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
425 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
4356 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · More than one race
|
7 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
7 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
1 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
7 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
10 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
6 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
12 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
2 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
7 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
7 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
8 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
75 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
All Parts Excluding Part A.2 and Parts J · Unknown or Not Reported
|
7 Participants
n=300 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
10 Participants
n=593 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
2 Participants
n=305 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
19 Participants
n=581 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
9 Participants
n=586 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=327 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
13 Participants
n=583 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=42 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=133 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
6 Participants
n=376 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
3 Participants
n=375 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=437 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
9 Participants
n=510 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
89 Participants
n=5148 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · American Indian or Alaska Native
|
—
|
—
|
1 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · Asian
|
—
|
—
|
1 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
1 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · Black or African American
|
—
|
—
|
10 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
18 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · White
|
—
|
—
|
117 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
41 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
45 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
203 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · More than one race
|
—
|
—
|
2 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
4 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
|
Race (NIH/OMB)
Part A.2 and Parts J · Unknown or Not Reported
|
—
|
—
|
4 Participants
n=135 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
0 Participants
n=50 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
5 Participants
n=235 Participants • Baseline characteristics data of Part A.2 and Parts J are reported in a separate row to avoid double-counting of the participants.
|
PRIMARY outcome
Timeframe: 7 days post-vaccinationPopulation: Solicited Safety Set included all participants who received IP and contributed any solicited AR data.
Solicited ARs (local and systemic) were collected in 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. All solicited ARs considered causally related to injection were graded 0-4 (per Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials); lower score indicates lower severity, and a higher score indicates greater severity. The Investigator reviewed whether the solicited AR was also to be recorded as an adverse event (AE). 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 A.1: mRNA-1273.211 50 μg
n=298 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=591 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
n=128 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
n=303 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
n=577 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
n=583 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
n=327 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
n=583 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
n=42 Participants
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
n=133 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
n=350 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
n=372 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
n=437 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
n=507 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Solicited Local and Systemic ARs
Any
|
270 Participants
|
554 Participants
|
113 Participants
|
290 Participants
|
532 Participants
|
548 Participants
|
307 Participants
|
550 Participants
|
41 Participants
|
113 Participants
|
300 Participants
|
323 Participants
|
380 Participants
|
443 Participants
|
44 Participants
|
38 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 1
|
140 Participants
|
215 Participants
|
70 Participants
|
95 Participants
|
260 Participants
|
193 Participants
|
134 Participants
|
213 Participants
|
11 Participants
|
59 Participants
|
184 Participants
|
203 Participants
|
220 Participants
|
219 Participants
|
28 Participants
|
23 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 2
|
98 Participants
|
250 Participants
|
27 Participants
|
144 Participants
|
201 Participants
|
248 Participants
|
127 Participants
|
227 Participants
|
25 Participants
|
43 Participants
|
88 Participants
|
93 Participants
|
125 Participants
|
165 Participants
|
10 Participants
|
14 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 3
|
32 Participants
|
88 Participants
|
16 Participants
|
51 Participants
|
71 Participants
|
107 Participants
|
46 Participants
|
110 Participants
|
5 Participants
|
11 Participants
|
28 Participants
|
27 Participants
|
35 Participants
|
59 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Solicited Local and Systemic ARs
Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post-vaccinationPopulation: Safety Set included all participants who received IP.
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. Number of participants with unsolicited AEs (SAEs and non-serious AEs) up to 28 days post-vaccination are reported in this outcome measure.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=300 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=593 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
n=135 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
n=305 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
n=581 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
n=586 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
n=327 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
n=583 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
n=42 Participants
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
n=133 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
n=376 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
n=375 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
n=437 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
n=510 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Unsolicited AEs
|
62 Participants
|
126 Participants
|
24 Participants
|
54 Participants
|
134 Participants
|
126 Participants
|
91 Participants
|
135 Participants
|
5 Participants
|
27 Participants
|
80 Participants
|
82 Participants
|
83 Participants
|
119 Participants
|
9 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to EOS (Day 366 for Parts A.1, B, C, D, E, and F; and Day 181 for Parts A.2, H, and J)Population: Safety Set included all participants who received IP.
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 included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that lead to an unscheduled visit to a healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or coronavirus disease 2019 \[COVID-19\] and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). Number of participants with SAEs, AESIs, MAAEs, and AEs leading to discontinuation up to the end of study (EOS) are reported in this outcome measure.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=300 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=593 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
n=135 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
n=305 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
n=581 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
n=586 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
n=327 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
n=583 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
n=42 Participants
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
n=133 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
n=376 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
n=375 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
n=437 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
n=510 Participants
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
n=50 Participants
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
MAAEs
|
201 Participants
|
388 Participants
|
58 Participants
|
183 Participants
|
380 Participants
|
417 Participants
|
242 Participants
|
401 Participants
|
34 Participants
|
78 Participants
|
279 Participants
|
271 Participants
|
292 Participants
|
253 Participants
|
27 Participants
|
24 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
SAEs
|
6 Participants
|
26 Participants
|
3 Participants
|
15 Participants
|
27 Participants
|
12 Participants
|
8 Participants
|
18 Participants
|
0 Participants
|
2 Participants
|
20 Participants
|
16 Participants
|
23 Participants
|
12 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
AESIs
|
3 Participants
|
16 Participants
|
1 Participants
|
14 Participants
|
24 Participants
|
28 Participants
|
6 Participants
|
25 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
14 Participants
|
19 Participants
|
9 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With SAEs, AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Study or Treatment Discontinuation
AEs Leading to Discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous human immunodeficiency virus (HIV) infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. Overall number of participants analyzed = participants evaluable for this outcome measure.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral severe acute respiratory syndrome coronavirus (SARS-CoV-2) (D614G) at Day 29 is reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). 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 replaced by the ULOQ if actual values were not available. LLOQ was 19.85 arbitrary units (AU)/milliliter (mL) and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
4713.5 titer
Interval 3513.5 to 6323.4
|
1897.1 titer
Interval 1433.8 to 2510.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titer (GMT) of Serum Pseudovirus Neutralizing Antibody (nAb) ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
5642.3 titer
Interval 4531.1 to 7025.9
|
2861.4 titer
Interval 2396.0 to 3417.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 is reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=70 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=74 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
2304.6 titer
Interval 1584.4 to 3352.0
|
379.3 titer
Interval 281.0 to 512.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
2945.2 titer
Interval 2259.1 to 3839.7
|
1121.4 titer
Interval 927.4 to 1356.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroresponse Rate (SRR) (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
100 percentage of participants
Interval 95.3 to 100.0
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
—
|
—
|
—
|
—
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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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|
Seroresponse Rate (SRR) (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
100 percentage of participants
Interval 95.3 to 100.0
|
100 percentage of participants
Interval 95.3 to 100.0
|
—
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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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PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=76 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
97.4 percentage of participants
Interval 90.8 to 99.7
|
98.7 percentage of participants
Interval 92.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 29 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
93.4 percentage of participants
Interval 85.3 to 97.8
|
96.1 percentage of participants
Interval 88.9 to 99.2
|
—
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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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—
|
—
|
PRIMARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=70 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=74 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
100 percentage of participants
Interval 94.9 to 100.0
|
86.5 percentage of participants
Interval 76.5 to 93.3
|
—
|
—
|
—
|
—
|
—
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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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|
SRR (Based on Pre-vaccination Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
100 percentage of participants
Interval 94.9 to 100.0
|
100 percentage of participants
Interval 95.1 to 100.0
|
—
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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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—
|
PRIMARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 181 are reported. mRNA-1273.214 (50 μg) as a second booster dose (Part A.2) was compared to mRNA-1273.211 (50 μg) as the first booster dose (Part A.1). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=70 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=74 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
SARS-CoV-2 (D614G) nAb
|
71.4 percentage of participants
Interval 59.4 to 81.6
|
79.7 percentage of participants
Interval 68.8 to 88.2
|
—
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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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SRR (Based on Pre-booster Baseline) For Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant and Ancestral SARS-CoV-2 at Day 181 - mRNA-1273.214 (50 μg) (Part A.2) Compared to mRNA-1273.211 (50 μg) (Part A.1)
Omicron BA.1 Variant (B.1.1.529) nAb
|
81.4 percentage of participants
Interval 70.3 to 89.7
|
78.4 percentage of participants
Interval 67.3 to 87.1
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—
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PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) at Day 29 is reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
2739.5 titer
Interval 2320.2 to 3234.6
|
1462.1 titer
Interval 1260.1 to 1696.4
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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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PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
99.6 percentage of participants
Interval 98.0 to 100.0
|
99.2 percentage of participants
Interval 97.2 to 99.9
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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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PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. Part F (Cohort 2) mRNA-1273.529 50 μg was compared to Part F (Cohort 2) mRNA-1273 50 μg. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
71.4 percentage of participants
Interval 65.7 to 76.7
|
53.5 percentage of participants
Interval 47.2 to 59.7
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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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PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 29 is reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=334 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb
|
5971.6 titer
Interval 5316.7 to 6707.2
|
5621.4 titer
Interval 5029.2 to 6283.4
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—
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—
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—
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—
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—
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GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Omicron BA.1 Variant (B.1.1.529) nAb
|
2370.5 titer
Interval 2068.8 to 2716.1
|
1462.1 titer
Interval 1260.1 to 1696.4
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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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PRIMARY outcome
Timeframe: Day 91Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) at Day 91 is reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=329 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=243 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Omicron BA.1 Variant (B.1.1.529) nAb
|
967.3 titer
Interval 835.0 to 1120.6
|
624.2 titer
Interval 533.1 to 730.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb
|
3431.5 titer
Interval 3066.7 to 3839.8
|
3447.1 titer
Interval 3054.7 to 3889.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=334 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
100 percentage of participants
Interval 98.9 to 100.0
|
99.2 percentage of participants
Interval 97.2 to 99.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 29 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=334 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 29 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
75.1 percentage of participants
Interval 70.2 to 79.7
|
53.5 percentage of participants
Interval 47.2 to 59.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 91Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 91 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=329 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=243 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
98.2 percentage of participants
Interval 96.1 to 99.3
|
96.3 percentage of participants
Interval 93.0 to 98.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 91Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Day 91 are reported. mRNA-1273.214 (Part G) was compared the mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=329 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=243 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Day 91 - mRNA-1273.214 (Part G) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
38.6 percentage of participants
Interval 33.3 to 44.1
|
17.7 percentage of participants
Interval 13.1 to 23.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
GMT of serum pseudovirus nAb ID50 titers against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 is reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=209 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Omicron Variant (BA.4/BA.5)
|
2322.6 titer
Interval 1919.9 to 2809.7
|
483.0 titer
Interval 423.1 to 551.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb
|
7328.4 titer
Interval 6390.6 to 8403.8
|
5621.4 titer
Interval 5029.2 to 6283.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=209 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Omicron Variant (BA.4/BA.5)
|
98.1 percentage of participants
Interval 95.2 to 99.5
|
86.3 percentage of participants
Interval 81.5 to 90.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb
|
100 percentage of participants
Interval 98.3 to 100.0
|
100 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 and ancestral SARS-CoV-2 (D614G) at Day 29 are reported. mRNA-1273.222 (Part H) was compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273). Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=209 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Omicron Variant (BA.4/BA.5)
|
91.4 percentage of participants
Interval 86.7 to 94.8
|
37.6 percentage of participants
Interval 31.7 to 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.4/BA.5 Variant and Ancestral SARS-CoV-2 (D614G) at Day 29 - mRNA-1273.222 (Part H) Compared to mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb
|
80.9 percentage of participants
Interval 74.9 to 86.0
|
43.0 percentage of participants
Interval 36.9 to 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
GMT of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the lower limit of detection (LOD) are replaced by 0.5 \* LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (XBB.1.5) nAb
|
1751.2 titer
Interval 1212.5 to 2529.4
|
2579.0 titer
Interval 1809.1 to 3676.7
|
—
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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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—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BA.4/BA.5) nAb
|
9600.1 titer
Interval 7392.8 to 12466.4
|
9673.4 titer
Interval 6965.6 to 13433.8
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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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—
|
—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BQ.1.1) nAb
|
1806.7 titer
Interval 1294.1 to 2522.2
|
1894.1 titer
Interval 1383.2 to 2593.6
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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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—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
GMT of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 \* LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (XBB.1.5) nAb
|
1985.5 titer
Interval 1388.7 to 2838.8
|
2710.6 titer
Interval 1778.3 to 4131.8
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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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|
GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BA.4/BA.5) nAb
|
10469.7 titer
Interval 7771.5 to 14104.8
|
11231.0 titer
Interval 7883.5 to 15999.9
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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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|
GMT of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BQ.1.1) nAb
|
1727.4 titer
Interval 1293.0 to 2307.6
|
1991.1 titer
Interval 1308.6 to 3029.5
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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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—
|
PRIMARY outcome
Timeframe: Day 15Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
GMFR of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 is reported. GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 \* LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (XBB.1.5) nAb
|
11.0 ratio
Interval 8.4 to 14.5
|
16.7 ratio
Interval 12.8 to 21.7
|
—
|
—
|
—
|
—
|
—
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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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|
Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BA.4/BA.5) nAb
|
5.0 ratio
Interval 3.8 to 6.6
|
6.3 ratio
Interval 4.8 to 8.2
|
—
|
—
|
—
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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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|
Geometric Mean Fold Rise (GMFR) of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BQ.1.1) nAb
|
5.7 ratio
Interval 4.5 to 7.2
|
5.9 ratio
Interval 4.8 to 7.4
|
—
|
—
|
—
|
—
|
—
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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: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
GMFR of serum pseudovirus nAb ID50 titers against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 is reported. GMFR measures the changes in immunogenicity titers or levels from Baseline within participants. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. Antibody values reported as below the LOD are replaced by 0.5 \* LOD. LOD was 10 AU/mL for ID50 titer against XBB.1.5 and BQ.1.1. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (XBB.1.5) nAb
|
12.5 ratio
Interval 9.6 to 16.3
|
17.5 ratio
Interval 13.0 to 23.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BA.4/BA.5) nAb
|
5.5 ratio
Interval 4.2 to 7.1
|
7.3 ratio
Interval 5.4 to 9.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMFR of Serum Pseudovirus nAb ID50 Titers Against SARS-CoV-2 XBB.1.5, BA.4/BA.5, and SARS-CoV-2 BQ.1.1 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
SARS-CoV-2 (BQ.1.1) nAb
|
5.4 ratio
Interval 4.3 to 7.0
|
6.2 ratio
Interval 4.6 to 8.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 15 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
|
100 percentage of participants
Interval 88.8 to 100.0
|
100 percentage of participants
Interval 90.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 15Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 15 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 15 - Part J: mRNA-1273.231 and mRNA-1273.815
|
61.2 percentage of participants
Interval 46.2 to 74.8
|
69.4 percentage of participants
Interval 54.6 to 81.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
|
100 percentage of participants
Interval 88.8 to 100.0
|
100 percentage of participants
Interval 90.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: PPIS included all participants who received study injection; had pre-booster and Day 15 nAb data; and who had no major protocol deviations that impacted key or critical data.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=49 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 29 - Part J: mRNA-1273.231 and mRNA-1273.815
|
61.2 percentage of participants
Interval 46.2 to 74.8
|
67.3 percentage of participants
Interval 52.5 to 80.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
GMT of serum pseudovirus nAb ID50 titers against ancestral SARS-CoV-2 (D614G) at Day 29 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
4951.8 titer
Interval 4349.0 to 5638.0
|
5621.4 titer
Interval 5029.2 to 6283.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
100 percentage of participants
Interval 98.7 to 100.0
|
100 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 29 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=273 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 29 - Part F (Cohort 2): mRNA-1273.529 and mRNA-1273
|
29.7 percentage of participants
Interval 24.3 to 35.5
|
43.0 percentage of participants
Interval 36.9 to 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Number analyzed' = participants evaluable at specified timepoints.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=334 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 29
|
100 percentage of participants
Interval 98.9 to 100.0
|
100 percentage of participants
Interval 98.6 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 91
|
100 percentage of participants
Interval 98.9 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 181
|
99.4 percentage of participants
Interval 97.7 to 99.9
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 366
|
97.9 percentage of participants
Interval 94.8 to 99.4
|
99.4 percentage of participants
Interval 96.9 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29, 91, 181, and 366Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Number analyzed' = participants evaluable at specified timepoints.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=334 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=258 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 29
|
53.9 percentage of participants
Interval 48.4 to 59.3
|
43.0 percentage of participants
Interval 36.9 to 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 91
|
27.4 percentage of participants
Interval 22.6 to 32.5
|
18.1 percentage of participants
Interval 13.5 to 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 181
|
29.5 percentage of participants
Interval 24.5 to 35.0
|
19.2 percentage of participants
Interval 14.4 to 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) on Days 29, 91, 181, and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 366
|
32.6 percentage of participants
Interval 26.1 to 39.7
|
27.9 percentage of participants
Interval 21.5 to 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
GMT of serum pseudovirus nAb ID50 titers against BA.4/BA.5 at Day 181 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)
|
1424.7 titer
Interval 1123.5 to 1806.7
|
—
|
—
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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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—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
GMT of serum pseudovirus nAb ID50 titers against ancestral SARS-CoV-2 (D614G) at Day 181 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
2906.6 titer
Interval 2465.4 to 3426.9
|
2393.3 titer
Interval 2047.4 to 2797.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)
|
89.9 percentage of participants
Interval 84.7 to 93.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
100 percentage of participants
Interval 98.1 to 100.0
|
99.6 percentage of participants
Interval 97.7 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against BA.4/BA.5 at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 36.7 AU/mL and ULOQ was 13705 AU/mL for ID50 titer against BA.4/BA.5.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against BA.4/BA.5 at Day 181 - mRNA-1273.222 (Part H)
|
77.2 percentage of participants
Interval 70.6 to 83.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 181Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against ancestral SARS-CoV-2 (D614G) at Day 181 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=189 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Ancestral SARS-CoV-2 (D614G) at Day 181 - mRNA-1273.222 (Part H) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
|
45.0 percentage of participants
Interval 37.7 to 52.4
|
19.2 percentage of participants
Interval 14.4 to 24.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 181 and 366Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Percentage of participants with seroresponse (based on the pre-vaccination baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=308 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 181
|
94.5 percentage of participants
Interval 91.3 to 96.7
|
90.3 percentage of participants
Interval 85.8 to 93.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
SRR (Based on the Pre-vaccination Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 366
|
94.8 percentage of participants
Interval 90.6 to 97.5
|
89.8 percentage of participants
Interval 84.4 to 93.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 181 and 366Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Percentage of participants with seroresponse (based on the pre-booster baseline) for pseudovirus nAb ID50 against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4 \* LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=308 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 181
|
40.9 percentage of participants
Interval 35.4 to 46.6
|
25.9 percentage of participants
Interval 20.5 to 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
|
SRR (Based on the Pre-booster Baseline) for Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) at Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
Day 366
|
52.8 percentage of participants
Interval 45.6 to 60.1
|
44.7 percentage of participants
Interval 37.3 to 52.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 181 and 366Population: PPIS-Neg included all participants who received study injection; had pre-booster and Day 29 nAb data; had no major protocol deviations that impacted key or critical data; had no previous HIV infection; and who had no serologic or virologic evidence of SARS-CoV-2 infection at baseline. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
GMT of serum pseudovirus nAb ID50 titers against Omicron BA.1 Variant (B.1.1.529) and ancestral SARS-CoV-2 (D614G) on Days 181 and 366 is reported. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were replaced by the ULOQ if actual values were not available. LLOQ was 19.85 AU/mL and ULOQ was 15502.7 AU/mL for ID50 titer against B.1.1.529. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer against ancestral SARS-CoV-2.
Outcome measures
| Measure |
Part A.1: mRNA-1273.211 50 μg
n=308 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 50 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.1: mRNA-1273.211 100 μg
n=239 Participants
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273.211 on Day 1 of Part A.1.
|
Part A.2: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) and a first booster dose of 50 μg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 μg of mRNA-1273.214 on Day 1 of Part A.2.
|
Part B: mRNA-1273 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 μg of mRNA-1273 on Day 1 of Part B.
|
Part C: mRNA-1273.617.2 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part C: mRNA-1273.617.2 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.617.2 on Day 1 of Part C.
|
Part D: mRNA-1273.213 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part D: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part D.
|
Part E: mRNA-1273.213 100 μg
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 μg of mRNA-1273.213 on Day 1 of Part E.
|
Part F (Cohort 1): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273 on Day 1 of Part F.
|
Part F (Cohort 2): mRNA-1273.529 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg in Study mRNA-1273-P301 (COVE) or under the EUA, received a second IM booster dose of 50 μg of mRNA-1273.529 on Day 1 of Part F.
|
Part G: mRNA-1273.214 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of mRNA-1273.214 50 μg on Day 1 of Part G.
|
Part H: mRNA-1273.222 50 μg
Participants who had previously received 2 doses of mRNA-1273 100 μg as a primary series and a single booster dose of mRNA-1273 50 μg, received a second IM booster dose of 50 μg of mRNA-1273.222 on Day 1 of Part H.
|
Part J: mRNA-1273.231 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 μg of mRNA-1273.231 on Day 1 of Part J.
|
Part J: mRNA-1273.815 50 μg
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 ug of mRNA-1273.815 on Day 1 of Part J.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) on Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (B.1.1.529) nAb: Day 181
|
1044.9 titer
Interval 853.5 to 1279.2
|
693.7 titer
Interval 550.7 to 873.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) on Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb: Day 181
|
2683.2 titer
Interval 2300.6 to 3129.5
|
2393.3 titer
Interval 2047.4 to 2797.6
|
—
|
—
|
—
|
—
|
—
|
—
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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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—
|
—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) on Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (B.1.1.529) nAb: Day 366
|
1364.6 titer
Interval 1050.0 to 1773.6
|
1019.7 titer
Interval 776.3 to 1339.4
|
—
|
—
|
—
|
—
|
—
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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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—
|
|
GMT of Serum Pseudovirus nAb ID50 Titers Against Omicron BA.1 Variant (B.1.1.529) and Ancestral SARS-CoV-2 (D614G) on Days 181 and 366 - mRNA-1273.214 (Part G) and mRNA-1273 (Part F, Cohort 2, 50 μg mRNA-1273)
SARS-CoV-2 (D614G) nAb: Day 366
|
2679.5 titer
Interval 2157.6 to 3327.5
|
2492.3 titer
Interval 2032.3 to 3056.5
|
—
|
—
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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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—
|
Adverse Events
Part A.1: mRNA-1273.211 50 µg
Serious events: 6 serious events
Other events: 133 other events
Deaths: 1 deaths
Part A.1: mRNA-1273.211 100 µg
Serious events: 26 serious events
Other events: 275 other events
Deaths: 0 deaths
Part A.2: mRNA-1273.214 50 µg
Serious events: 3 serious events
Other events: 38 other events
Deaths: 0 deaths
Part B: mRNA-1273 100 µg
Serious events: 15 serious events
Other events: 144 other events
Deaths: 1 deaths
Part C: mRNA-1273.617.2 50 µg
Serious events: 27 serious events
Other events: 288 other events
Deaths: 0 deaths
Part C: mRNA-1273.617.2 100 µg
Serious events: 12 serious events
Other events: 329 other events
Deaths: 1 deaths
Part D: mRNA-1273.213 50 µg
Serious events: 8 serious events
Other events: 188 other events
Deaths: 0 deaths
Part D: mRNA-1273.213 100 µg
Serious events: 18 serious events
Other events: 309 other events
Deaths: 0 deaths
Part E: mRNA-1273.213 100 µg
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Part F (Cohort 1): mRNA-1273.529 50 µg
Serious events: 2 serious events
Other events: 57 other events
Deaths: 0 deaths
Part F (Cohort 2): mRNA-1273 50 µg
Serious events: 20 serious events
Other events: 193 other events
Deaths: 2 deaths
Part F (Cohort 2): mRNA-1273.529 50 µg
Serious events: 16 serious events
Other events: 188 other events
Deaths: 0 deaths
Part G: mRNA-1273.214 50 µg
Serious events: 23 serious events
Other events: 224 other events
Deaths: 2 deaths
Part H: mRNA-1273.222 50 µg
Serious events: 12 serious events
Other events: 178 other events
Deaths: 2 deaths
Part J: mRNA-1273.231 50 µg
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Part J: mRNA-1273.815 50 µg
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A.1: mRNA-1273.211 50 µg
n=300 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single intramuscular (IM) booster dose of 50 micrograms (µg) of mRNA-1273.211 on Day 1 of Part A.1
|
Part A.1: mRNA-1273.211 100 µg
n=593 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 µg of mRNA-1273.211 on Day 1 of Part A.1
|
Part A.2: mRNA-1273.214 50 µg
n=135 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series and a first booster dose of 50 µg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 µg of mRNA-1273.214 on Day 1 of Part A.2
|
Part B: mRNA-1273 100 µg
n=305 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 µg of mRNA-1273 on Day 1 of Part B
|
Part C: mRNA-1273.617.2 50 µg
n=581 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 µg of mRNA-1273.617.2 on Day 1 of Part C
|
Part C: mRNA-1273.617.2 100 µg
n=586 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 µg of mRNA-1273.617.2 on Day 1 of Part C
|
Part D: mRNA-1273.213 50 µg
n=327 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 µg of mRNA-1273.213 on Day 1 of Part D
|
Part D: mRNA-1273.213 100 µg
n=583 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 µg of mRNA-1273.213 on Day 1 of Part D
|
Part E: mRNA-1273.213 100 µg
n=42 participants at risk
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 µg of mRNA-1273.213 on Day 1 of Part E
|
Part F (Cohort 1): mRNA-1273.529 50 µg
n=133 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 µg of mRNA-1273.529 on Day 1 of Part F
|
Part F (Cohort 2): mRNA-1273 50 µg
n=376 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273 on Day 1 of Part F
|
Part F (Cohort 2): mRNA-1273.529 50 µg
n=375 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273.529 on Day 1 of Part F
|
Part G: mRNA-1273.214 50 µg
n=437 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of mRNA-1273.214 50 µg on Day 1 of Part G
|
Part H: mRNA-1273.222 50 µg
n=510 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273.222 on Day 1 of Part H
|
Part J: mRNA-1273.231 50 µg
n=50 participants at risk
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 µg of mRNA-1273.231 on Day 1 of Part J
|
Part J: mRNA-1273.815 50 µg
n=50 participants at risk
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 µg of mRNA-1273.815 on Day 1 of Part J
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
COVID-19
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.74%
1/135 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Campylobacter colitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Candida infection
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Fungaemia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Gangrene
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Neurosyphilis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/583 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Sepsis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Septic shock
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.51%
3/593 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic malignant fibrous histiocytoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.74%
1/135 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Psychiatric disorders
Depression
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Aqueductal stenosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Migraine
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.74%
1/135 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Seizure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Syncope
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/593 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.52%
3/581 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Anginal equivalent
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.66%
2/305 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.53%
2/376 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.53%
2/375 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.46%
2/437 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.53%
2/375 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Myocarditis
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/581 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Haematoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Hypertension
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Hypotension
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.75%
1/133 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.67%
2/300 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.67%
4/593 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/581 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.80%
3/376 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.31%
1/327 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.33%
1/300 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/583 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Renal and urinary disorders
Renal vascular thrombosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/583 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Chest pain
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Death
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.75%
1/133 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Peripheral swelling
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/376 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Investigations
Myocardial necrosis marker increased
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Investigations
Staphylococcus test positive
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Investigations
Transaminases increased
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.27%
1/375 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.23%
1/437 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/305 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Product Issues
Device failure
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/581 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/586 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/510 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
Other adverse events
| Measure |
Part A.1: mRNA-1273.211 50 µg
n=300 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single intramuscular (IM) booster dose of 50 micrograms (µg) of mRNA-1273.211 on Day 1 of Part A.1
|
Part A.1: mRNA-1273.211 100 µg
n=593 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 µg of mRNA-1273.211 on Day 1 of Part A.1
|
Part A.2: mRNA-1273.214 50 µg
n=135 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series and a first booster dose of 50 µg of the mRNA-1273.211 in Part A.1 of this study, received a second IM booster dose of 50 µg of mRNA-1273.214 on Day 1 of Part A.2
|
Part B: mRNA-1273 100 µg
n=305 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE), received a single IM booster dose of 100 µg of mRNA-1273 on Day 1 of Part B
|
Part C: mRNA-1273.617.2 50 µg
n=581 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 µg of mRNA-1273.617.2 on Day 1 of Part C
|
Part C: mRNA-1273.617.2 100 µg
n=586 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 µg of mRNA-1273.617.2 on Day 1 of Part C
|
Part D: mRNA-1273.213 50 µg
n=327 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 50 µg of mRNA-1273.213 on Day 1 of Part D
|
Part D: mRNA-1273.213 100 µg
n=583 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series in Study mRNA-1273-P301 (COVE) or under the EUA, received a single IM booster dose of 100 µg of mRNA-1273.213 on Day 1 of Part D
|
Part E: mRNA-1273.213 100 µg
n=42 participants at risk
Participants who had previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine as a primary series (with a subset of enrolled participants who previously received Moderna's mRNA-1273 authorized vaccine as a primary series), received a single IM booster dose of 100 µg of mRNA-1273.213 on Day 1 of Part E
|
Part F (Cohort 1): mRNA-1273.529 50 µg
n=133 participants at risk
Participants who had previously received 2 doses of mRNA-1273 as a primary series, received a single IM booster dose of 50 µg of mRNA-1273.529 on Day 1 of Part F
|
Part F (Cohort 2): mRNA-1273 50 µg
n=376 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273 on Day 1 of Part F
|
Part F (Cohort 2): mRNA-1273.529 50 µg
n=375 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273.529 on Day 1 of Part F
|
Part G: mRNA-1273.214 50 µg
n=437 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of mRNA-1273.214 50 µg on Day 1 of Part G
|
Part H: mRNA-1273.222 50 µg
n=510 participants at risk
Participants who had previously received 2 doses of mRNA-1273 100 µg as a primary series and a single booster dose of mRNA-1273 50 µg, received a second IM booster dose of 50 µg of mRNA-1273.222 on Day 1 of Part H
|
Part J: mRNA-1273.231 50 µg
n=50 participants at risk
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 µg of mRNA-1273.231 on Day 1 of Part J
|
Part J: mRNA-1273.815 50 µg
n=50 participants at risk
Participants who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-CoV-2, received a third IM booster dose of 50 µg of mRNA-1273.815 on Day 1 of Part J
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Asymptomatic COVID-19
|
4.7%
14/300 • Number of events 15 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.7%
40/593 • Number of events 41 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.2%
7/135 • Number of events 7 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.6%
20/305 • Number of events 21 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.8%
28/581 • Number of events 28 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.6%
21/586 • Number of events 22 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
10.1%
33/327 • Number of events 34 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.4%
14/583 • Number of events 14 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
11.9%
5/42 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
9.0%
12/133 • Number of events 13 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.6%
21/376 • Number of events 21 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
7.2%
27/375 • Number of events 27 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.1%
18/437 • Number of events 19 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.7%
24/510 • Number of events 24 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Bronchitis
|
1.3%
4/300 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.0%
6/593 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.2%
16/305 • Number of events 17 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.86%
5/581 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.2%
7/586 • Number of events 7 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.5%
5/327 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.1%
24/583 • Number of events 26 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.4%
1/42 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.5%
2/133 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.9%
7/376 • Number of events 7 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.3%
5/375 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.8%
8/437 • Number of events 8 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.78%
4/510 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
COVID-19
|
25.3%
76/300 • Number of events 76 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
24.1%
143/593 • Number of events 144 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
15.6%
21/135 • Number of events 21 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
28.5%
87/305 • Number of events 90 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
33.6%
195/581 • Number of events 201 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
38.7%
227/586 • Number of events 235 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
35.8%
117/327 • Number of events 124 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
37.7%
220/583 • Number of events 226 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
42.9%
18/42 • Number of events 18 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
22.6%
30/133 • Number of events 30 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
33.8%
127/376 • Number of events 132 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
31.7%
119/375 • Number of events 121 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
36.6%
160/437 • Number of events 164 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
14.5%
74/510 • Number of events 76 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
10.0%
5/50 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.0%
2/50 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/593 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.2%
16/305 • Number of events 20 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.34%
2/581 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.4%
8/586 • Number of events 9 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.69%
4/583 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
9.5%
4/42 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.53%
2/376 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/375 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/437 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.2%
6/510 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Rhinovirus infection
|
4.7%
14/300 • Number of events 16 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.2%
19/593 • Number of events 20 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.0%
4/135 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.0%
9/305 • Number of events 10 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.8%
22/581 • Number of events 24 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.1%
36/586 • Number of events 39 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.4%
11/327 • Number of events 11 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.3%
25/583 • Number of events 26 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
7.1%
3/42 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.8%
5/133 • Number of events 5 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.8%
18/376 • Number of events 19 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.9%
11/375 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.2%
27/437 • Number of events 28 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.9%
25/510 • Number of events 27 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.0%
3/50 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
10.0%
5/50 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.0%
27/300 • Number of events 28 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
10.6%
63/593 • Number of events 79 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.4%
6/135 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.9%
21/305 • Number of events 22 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.4%
49/581 • Number of events 62 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.4%
49/586 • Number of events 57 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
11.6%
38/327 • Number of events 51 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
9.1%
53/583 • Number of events 61 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
35.7%
15/42 • Number of events 15 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.8%
9/133 • Number of events 10 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.8%
33/376 • Number of events 41 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.3%
31/375 • Number of events 36 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.2%
36/437 • Number of events 39 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
7.1%
36/510 • Number of events 38 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.0%
4/50 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.0%
2/50 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Nervous system disorders
Headache
|
2.0%
6/300 • Number of events 7 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.0%
24/593 • Number of events 24 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.2%
3/135 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
6/305 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.6%
27/581 • Number of events 30 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.5%
32/586 • Number of events 34 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.1%
10/327 • Number of events 11 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.1%
24/583 • Number of events 25 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.4%
1/42 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
9.0%
12/133 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.4%
9/376 • Number of events 13 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.0%
15/375 • Number of events 18 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.5%
11/437 • Number of events 11 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.1%
21/510 • Number of events 22 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.0%
2/50 • Number of events 2 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Vascular disorders
Hypertension
|
4.0%
12/300 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.4%
20/593 • Number of events 22 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.3%
10/305 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.2%
13/581 • Number of events 13 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.4%
20/586 • Number of events 20 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.2%
17/327 • Number of events 17 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.9%
11/583 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.3%
3/133 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.8%
18/376 • Number of events 18 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.3%
16/375 • Number of events 16 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.0%
13/437 • Number of events 13 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
1.6%
8/510 • Number of events 8 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/300 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/593 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/135 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.33%
1/305 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/581 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.17%
1/586 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/327 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/583 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
9.5%
4/42 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/133 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/376 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.80%
3/375 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.69%
3/437 • Number of events 3 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.20%
1/510 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
|
General disorders
Fatigue
|
4.0%
12/300 • Number of events 14 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
6.1%
36/593 • Number of events 38 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.0%
4/135 • Number of events 4 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
6/305 • Number of events 6 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.2%
30/581 • Number of events 34 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.9%
29/586 • Number of events 31 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
7.3%
24/327 • Number of events 25 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
5.7%
33/583 • Number of events 35 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/42 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
8.3%
11/133 • Number of events 12 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.8%
18/376 • Number of events 20 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.5%
17/375 • Number of events 20 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
3.4%
15/437 • Number of events 17 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
4.9%
25/510 • Number of events 26 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
2.0%
1/50 • Number of events 1 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
|
0.00%
0/50 • Day 1 up to the end of the study (Day 366 for Parts A.1, B, C, D, F, and G; Day 181 for Parts A.2, H, J)
The all-cause mortality was based on the full analysis set. The serious and other (not including serious) adverse events were based on the safety set which consisted of all participants who received the study vaccination.
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Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc.
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place