Trial Outcomes & Findings for A Study About Modified RNA Vaccines Against Influenza in Healthy Adults (NCT NCT06436703)
NCT ID: NCT06436703
Last Updated: 2026-06-12
Results Overview
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1202 participants
Primary outcome timeframe
From study vaccination on Day 1 through 6 months after study vaccination
Results posted on
2026-06-12
Participant Flow
This study was conducted across 3 sub studies: Substudy A (SSA), Substudy B (SSB) and Substudy C (SSC). A total of 1202 participants (SSA = 481; SSB = 450; SSC =271) were enrolled. Each participant was enrolled in only one substudy and randomized to a single study group.
Dose levels for nucleoside-modified ribonucleic acid (modRNA) vaccines are in numerical order from lowest to highest total modRNA dose, i.e., dose level 1 represents the lowest total modRNA dose and dose level 7 represents the highest total modRNA dose. Trivalent modRNA vaccines identified as formulation 3 encode for additional influenza strain-specific antigens.
Participant milestones
| Measure |
SSC: Influenza ModRNA Vaccine 5C
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
|
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose quadrivalent influenza vaccine (QIV 1) at licensed dose intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 3B
Participants aged more than or equal to (\>=) 65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 4B
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 5B
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 6C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 7C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
97
|
97
|
96
|
97
|
94
|
90
|
87
|
90
|
89
|
94
|
30
|
30
|
30
|
30
|
30
|
31
|
30
|
30
|
|
Overall Study
Vaccinated
|
30
|
96
|
96
|
96
|
97
|
94
|
90
|
87
|
90
|
89
|
94
|
30
|
30
|
30
|
30
|
30
|
31
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
91
|
91
|
92
|
92
|
89
|
90
|
86
|
88
|
89
|
93
|
30
|
29
|
30
|
30
|
29
|
30
|
30
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
6
|
4
|
5
|
5
|
0
|
1
|
2
|
0
|
1
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
SSC: Influenza ModRNA Vaccine 5C
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 2A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 3A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 4A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 5A
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
|
SSA: QIV 1
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose quadrivalent influenza vaccine (QIV 1) at licensed dose intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 3B
Participants aged more than or equal to (\>=) 65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 4B
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 5B
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 6C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 7C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Not Vaccinated
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
4
|
3
|
4
|
4
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
No longer met eligibility criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study About Modified RNA Vaccines Against Influenza in Healthy Adults
Baseline characteristics by cohort
| Measure |
SSA: Influenza ModRNA Vaccine 2A
n=96 Participants
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 3A
n=96 Participants
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 4A
n=96 Participants
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 5A
n=97 Participants
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
|
SSA: QIV 1
n=94 Participants
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 3B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 4B
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 5B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 5C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 6C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 7C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
Total
n=1200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.6 Years
STANDARD_DEVIATION 12.42 • n=9 Participants
|
44.2 Years
STANDARD_DEVIATION 12.44 • n=27 Participants
|
44.9 Years
STANDARD_DEVIATION 12.43 • n=267 Participants
|
43.8 Years
STANDARD_DEVIATION 13.36 • n=265 Participants
|
43.8 Years
STANDARD_DEVIATION 11.93 • n=568 Participants
|
71.2 Years
STANDARD_DEVIATION 4.73 • n=22 Participants
|
70.8 Years
STANDARD_DEVIATION 4.12 • n=23 Participants
|
71.1 Years
STANDARD_DEVIATION 4.99 • n=22 Participants
|
72.2 Years
STANDARD_DEVIATION 4.60 • n=178 Participants
|
71.1 Years
STANDARD_DEVIATION 5.12 • n=116 Participants
|
71.3 Years
STANDARD_DEVIATION 4.12 • n=2 Participants
|
70.2 Years
STANDARD_DEVIATION 4.63 • n=4 Participants
|
70.1 Years
STANDARD_DEVIATION 4.61 • n=190 Participants
|
70.6 Years
STANDARD_DEVIATION 4.80 • n=19 Participants
|
71.5 Years
STANDARD_DEVIATION 5.61 • n=18 Participants
|
71.3 Years
STANDARD_DEVIATION 5.50 • n=18 Participants
|
71.0 Years
STANDARD_DEVIATION 5.12 • n=14 Participants
|
72.1 Years
STANDARD_DEVIATION 5.66 • n=16 Participants
|
69.2 Years
STANDARD_DEVIATION 4.72 • n=17 Participants
|
60.4 Years
STANDARD_DEVIATION 15.79 • n=18 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=9 Participants
|
53 Participants
n=27 Participants
|
62 Participants
n=267 Participants
|
57 Participants
n=265 Participants
|
51 Participants
n=568 Participants
|
47 Participants
n=22 Participants
|
51 Participants
n=23 Participants
|
50 Participants
n=22 Participants
|
47 Participants
n=178 Participants
|
48 Participants
n=116 Participants
|
16 Participants
n=2 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=190 Participants
|
17 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
13 Participants
n=18 Participants
|
14 Participants
n=14 Participants
|
18 Participants
n=16 Participants
|
10 Participants
n=17 Participants
|
673 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=9 Participants
|
43 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
40 Participants
n=265 Participants
|
43 Participants
n=568 Participants
|
43 Participants
n=22 Participants
|
36 Participants
n=23 Participants
|
40 Participants
n=22 Participants
|
42 Participants
n=178 Participants
|
46 Participants
n=116 Participants
|
14 Participants
n=2 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=190 Participants
|
13 Participants
n=19 Participants
|
12 Participants
n=18 Participants
|
17 Participants
n=18 Participants
|
17 Participants
n=14 Participants
|
12 Participants
n=16 Participants
|
20 Participants
n=17 Participants
|
527 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
11 Participants
n=568 Participants
|
6 Participants
n=22 Participants
|
7 Participants
n=23 Participants
|
9 Participants
n=22 Participants
|
9 Participants
n=178 Participants
|
11 Participants
n=116 Participants
|
11 Participants
n=2 Participants
|
18 Participants
n=4 Participants
|
10 Participants
n=190 Participants
|
11 Participants
n=19 Participants
|
12 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
12 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
17 Participants
n=17 Participants
|
222 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=9 Participants
|
78 Participants
n=27 Participants
|
76 Participants
n=267 Participants
|
81 Participants
n=265 Participants
|
82 Participants
n=568 Participants
|
84 Participants
n=22 Participants
|
78 Participants
n=23 Participants
|
79 Participants
n=22 Participants
|
79 Participants
n=178 Participants
|
82 Participants
n=116 Participants
|
19 Participants
n=2 Participants
|
12 Participants
n=4 Participants
|
20 Participants
n=190 Participants
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
22 Participants
n=18 Participants
|
18 Participants
n=14 Participants
|
20 Participants
n=16 Participants
|
13 Participants
n=17 Participants
|
965 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
13 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
1 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=23 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=178 Participants
|
4 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=190 Participants
|
2 Participants
n=19 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
50 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=9 Participants
|
22 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
28 Participants
n=265 Participants
|
21 Participants
n=568 Participants
|
14 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
15 Participants
n=22 Participants
|
14 Participants
n=178 Participants
|
10 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=190 Participants
|
4 Participants
n=19 Participants
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=16 Participants
|
7 Participants
n=17 Participants
|
217 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
67 Participants
n=9 Participants
|
65 Participants
n=27 Participants
|
62 Participants
n=267 Participants
|
63 Participants
n=265 Participants
|
66 Participants
n=568 Participants
|
71 Participants
n=22 Participants
|
68 Participants
n=23 Participants
|
70 Participants
n=22 Participants
|
71 Participants
n=178 Participants
|
74 Participants
n=116 Participants
|
28 Participants
n=2 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=190 Participants
|
24 Participants
n=19 Participants
|
25 Participants
n=18 Participants
|
25 Participants
n=18 Participants
|
28 Participants
n=14 Participants
|
27 Participants
n=16 Participants
|
23 Participants
n=17 Participants
|
905 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
15 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
3 Participants
n=116 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=190 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=17 Participants
|
8 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the electronic dairy (e-diary) or by investigators in case report form (CRF) after vaccination. All local reactions were graded based on center for biologics evaluation and research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
|
80.2 Percentage of participants
Interval 70.8 to 87.6
|
73.2 Percentage of participants
Interval 63.2 to 81.7
|
42.6 Percentage of participants
Interval 32.4 to 53.2
|
83.3 Percentage of participants
Interval 74.4 to 90.2
|
84.0 Percentage of participants
Interval 75.0 to 90.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=92 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
|
68.2 Percentage of participants
Interval 57.4 to 77.7
|
43.2 Percentage of participants
Interval 32.7 to 54.2
|
42.4 Percentage of participants
Interval 32.1 to 53.1
|
66.7 Percentage of participants
Interval 55.9 to 76.3
|
64.0 Percentage of participants
Interval 52.9 to 74.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention.
Local reactions included pain at the injection site, redness and swelling and were recorded by participants in the e-diary or by investigators in CRF after vaccination. All local reactions were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any local reaction of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With Local Reactions for up to 7 Days Following Vaccination
|
73.3 Percentage of participants
Interval 54.1 to 87.7
|
70.0 Percentage of participants
Interval 50.6 to 85.3
|
73.3 Percentage of participants
Interval 54.1 to 87.7
|
76.7 Percentage of participants
Interval 57.7 to 90.1
|
43.3 Percentage of participants
Interval 25.5 to 62.6
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
61.3 Percentage of participants
Interval 42.2 to 78.2
|
46.7 Percentage of participants
Interval 28.3 to 65.7
|
50.0 Percentage of participants
Interval 31.3 to 68.7
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
|
76.0 Percentage of participants
Interval 66.3 to 84.2
|
75.3 Percentage of participants
Interval 65.5 to 83.5
|
53.2 Percentage of participants
Interval 42.6 to 63.6
|
68.8 Percentage of participants
Interval 58.5 to 77.8
|
76.6 Percentage of participants
Interval 66.7 to 84.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response (yes or no) in the e-diary or CRF after vaccination.
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=92 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
|
58.0 Percentage of participants
Interval 47.0 to 68.4
|
33.0 Percentage of participants
Interval 23.3 to 43.8
|
34.8 Percentage of participants
Interval 25.1 to 45.4
|
56.7 Percentage of participants
Interval 45.8 to 67.1
|
58.1 Percentage of participants
Interval 47.0 to 68.7
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after study vaccination [Vaccination on Day 1]Population: Safety population included all participants who received the study intervention.
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, new or worsened muscle pain and joint pain) were recorded by participants in the e-diary or by investigators in CRF after vaccination. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure, data is reported as percentage of participants with any systemic events of any grade.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With Systemic Events for up to 7 Days Following Vaccination
|
63.3 Percentage of participants
Interval 43.9 to 80.1
|
53.3 Percentage of participants
Interval 34.3 to 71.7
|
56.7 Percentage of participants
Interval 37.4 to 74.5
|
56.7 Percentage of participants
Interval 37.4 to 74.5
|
53.3 Percentage of participants
Interval 34.3 to 71.7
|
80.0 Percentage of participants
Interval 61.4 to 92.3
|
61.3 Percentage of participants
Interval 42.2 to 78.2
|
43.3 Percentage of participants
Interval 25.5 to 62.6
|
36.7 Percentage of participants
Interval 19.9 to 56.1
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Adverse Events (AEs) From Vaccination Through 4 Weeks After Vaccination
|
3.1 Percentage of participants
Interval 0.6 to 8.9
|
8.2 Percentage of participants
Interval 3.6 to 15.6
|
6.4 Percentage of participants
Interval 2.4 to 13.4
|
5.2 Percentage of participants
Interval 1.7 to 11.7
|
8.3 Percentage of participants
Interval 3.7 to 15.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
|
8.9 Percentage of participants
Interval 3.9 to 16.8
|
6.7 Percentage of participants
Interval 2.5 to 14.1
|
4.3 Percentage of participants
Interval 1.2 to 10.5
|
8.9 Percentage of participants
Interval 3.9 to 16.8
|
8.0 Percentage of participants
Interval 3.3 to 15.9
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 4 weeks after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With AEs From Vaccination Through 4 Weeks After Vaccination
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
3.2 Percentage of participants
Interval 0.1 to 16.7
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.7
|
0 Percentage of participants
Interval 0.0 to 3.8
|
2.1 Percentage of participants
Interval 0.3 to 7.3
|
0 Percentage of participants
Interval 0.0 to 3.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
|
4.4 Percentage of participants
Interval 1.2 to 11.0
|
3.4 Percentage of participants
Interval 0.7 to 9.5
|
2.1 Percentage of participants
Interval 0.3 to 7.5
|
0 Percentage of participants
Interval 0.0 to 4.0
|
4.6 Percentage of participants
Interval 1.3 to 11.4
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, any other pre-specified criteria in protocol of the study or other important medical event judged by the investigator.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With SAEs From Vaccination Through 6 Months After Vaccination
|
0 Percentage of participants
Interval 0.0 to 11.6
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
3.2 Percentage of participants
Interval 0.1 to 16.7
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Medically Attended Adverse Events (MAEs) From Vaccination Through 6 Months After Vaccination
|
3.1 Percentage of participants
Interval 0.6 to 8.9
|
8.2 Percentage of participants
Interval 3.6 to 15.6
|
6.4 Percentage of participants
Interval 2.4 to 13.4
|
5.2 Percentage of participants
Interval 1.7 to 11.7
|
9.4 Percentage of participants
Interval 4.4 to 17.1
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
|
7.8 Percentage of participants
Interval 3.2 to 15.4
|
11.2 Percentage of participants
Interval 5.5 to 19.7
|
7.4 Percentage of participants
Interval 3.0 to 14.7
|
10.0 Percentage of participants
Interval 4.7 to 18.1
|
12.6 Percentage of participants
Interval 6.5 to 21.5
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With MAEs From Vaccination Through 6 Months After Vaccination
|
16.7 Percentage of participants
Interval 5.6 to 34.7
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
0 Percentage of participants
Interval 0.0 to 11.6
|
10.0 Percentage of participants
Interval 2.1 to 26.5
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
6.7 Percentage of participants
Interval 0.8 to 22.1
|
6.5 Percentage of participants
Interval 0.8 to 21.4
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=97 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=96 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination Through 6 Months After Vaccination
|
0 Percentage of participants
Interval 0.0 to 3.8
|
4.1 Percentage of participants
Interval 1.1 to 10.2
|
1.1 Percentage of participants
Interval 0.0 to 5.8
|
0 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 3.8
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
|
2.2 Percentage of participants
Interval 0.3 to 7.8
|
3.4 Percentage of participants
Interval 0.7 to 9.5
|
2.1 Percentage of participants
Interval 0.3 to 7.5
|
0 Percentage of participants
Interval 0.0 to 4.0
|
1.1 Percentage of participants
Interval 0.0 to 6.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From study vaccination on Day 1 through 6 months after study vaccinationPopulation: Safety population included all participants who received the study intervention.
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects (e.g., asthma).
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSC: Percentage of Participants With NDCMCs From Vaccination Through 6 Months After Vaccination
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.6
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
0 Percentage of participants
Interval 0.0 to 11.2
|
3.3 Percentage of participants
Interval 0.1 to 17.2
|
0 Percentage of participants
Interval 0.0 to 11.6
|
SECONDARY outcome
Timeframe: Baseline (before study vaccination on Day 1), 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population: All eligible participants who received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame after vaccination, had at least 1 valid and determinate assay result at the 4-week postvaccination visit, and had no major protocol violations. Here, Number Analyzed=number of participants evaluable for the specified rows.
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution).
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=84 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
A/H1N1: Before Vaccination
|
29.4 Titers
Interval 22.8 to 37.9
|
23.0 Titers
Interval 17.0 to 31.1
|
23.7 Titers
Interval 18.2 to 30.9
|
26.7 Titers
Interval 20.4 to 35.0
|
24.2 Titers
Interval 18.7 to 31.3
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
A/H1N1: 4 Weeks After Vaccination
|
202.1 Titers
Interval 160.9 to 253.9
|
169.8 Titers
Interval 126.4 to 228.3
|
129.8 Titers
Interval 97.0 to 173.6
|
167.4 Titers
Interval 130.0 to 215.7
|
160.4 Titers
Interval 126.5 to 203.5
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
A/H3N2: Before Vaccination
|
39.0 Titers
Interval 31.2 to 48.7
|
39.0 Titers
Interval 31.8 to 47.9
|
33.6 Titers
Interval 26.3 to 42.9
|
40.0 Titers
Interval 32.0 to 50.0
|
33.6 Titers
Interval 27.5 to 41.2
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
A/H3N2: 4 Weeks After Vaccination
|
199.3 Titers
Interval 159.6 to 248.9
|
240.2 Titers
Interval 193.0 to 298.8
|
90.9 Titers
Interval 68.0 to 121.5
|
207.6 Titers
Interval 162.7 to 265.0
|
176.8 Titers
Interval 141.9 to 220.2
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
B/Victoria: Before Vaccination
|
18.9 Titers
Interval 15.0 to 23.8
|
15.3 Titers
Interval 12.0 to 19.5
|
16.7 Titers
Interval 12.9 to 21.6
|
17.7 Titers
Interval 13.9 to 22.7
|
17.0 Titers
Interval 13.4 to 21.5
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
B/Victoria: 4 Weeks After Vaccination
|
45.3 Titers
Interval 36.1 to 56.7
|
32.6 Titers
Interval 24.5 to 43.4
|
54.1 Titers
Interval 41.0 to 71.4
|
58.9 Titers
Interval 45.6 to 76.0
|
50.7 Titers
Interval 40.5 to 63.4
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
B/Yamagata: Before Vaccination
|
26.5 Titers
Interval 22.1 to 31.7
|
28.4 Titers
Interval 22.7 to 35.6
|
28.2 Titers
Interval 22.8 to 34.9
|
36.6 Titers
Interval 29.6 to 45.2
|
33.3 Titers
Interval 26.7 to 41.6
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Titers (GMTs) of Strain-Specific Hemagglutination Inhibition Assay (HAI) Titers at Baseline and 4 Weeks After Vaccination
B/Yamagata: 4 Weeks After Vaccination
|
29.0 Titers
Interval 24.3 to 34.7
|
59.2 Titers
Interval 47.1 to 74.3
|
59.6 Titers
Interval 47.2 to 75.4
|
38.1 Titers
Interval 30.7 to 47.2
|
38.8 Titers
Interval 31.5 to 47.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From before study vaccination on Day 1 up to 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
GMFR was defined as the geometric mean of the fold rise in the assay results from before vaccination to a specified time point after vaccination.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=84 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
A/H1N1
|
6.1 Fold Rise
Interval 4.8 to 7.7
|
6.0 Fold Rise
Interval 4.7 to 7.7
|
4.7 Fold Rise
Interval 3.4 to 6.5
|
5.4 Fold Rise
Interval 4.4 to 6.7
|
5.6 Fold Rise
Interval 4.5 to 6.9
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
A/H3N2
|
4.9 Fold Rise
Interval 3.8 to 6.2
|
5.7 Fold Rise
Interval 4.5 to 7.1
|
2.5 Fold Rise
Interval 1.9 to 3.2
|
4.9 Fold Rise
Interval 3.9 to 6.3
|
5.0 Fold Rise
Interval 4.0 to 6.1
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
B/Victoria
|
2.2 Fold Rise
Interval 1.8 to 2.6
|
1.9 Fold Rise
Interval 1.6 to 2.3
|
2.7 Fold Rise
Interval 2.1 to 3.3
|
2.9 Fold Rise
Interval 2.4 to 3.5
|
2.5 Fold Rise
Interval 2.1 to 3.0
|
—
|
—
|
—
|
—
|
|
SSA: Geometric Mean Fold Rise (GMFR) of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
B/Yamagata
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.9 Fold Rise
Interval 1.6 to 2.2
|
2.0 Fold Rise
Interval 1.6 to 2.5
|
1.0 Fold Rise
Interval 0.9 to 1.2
|
1.1 Fold Rise
Interval 1.0 to 1.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Seroconversion was defined as an HAI titer \<1:10 prior to vaccination and \>=1:40 at the time point of interest, or an HAI titer of \>=1:10 prior to vaccination with at least a 4-fold rise at the time point of interest.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=84 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
A/H1N1
|
78.3 Percentage of participants
Interval 67.9 to 86.6
|
71.8 Percentage of participants
Interval 61.0 to 81.0
|
50.6 Percentage of participants
Interval 39.5 to 61.6
|
72.1 Percentage of participants
Interval 61.4 to 81.2
|
75.0 Percentage of participants
Interval 64.6 to 83.6
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
A/H3N2
|
66.3 Percentage of participants
Interval 55.1 to 76.3
|
74.7 Percentage of participants
Interval 64.0 to 83.6
|
39.5 Percentage of participants
Interval 28.8 to 51.0
|
64.0 Percentage of participants
Interval 52.9 to 74.0
|
71.6 Percentage of participants
Interval 61.0 to 80.7
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
B/Victoria
|
32.1 Percentage of participants
Interval 22.4 to 43.2
|
24.7 Percentage of participants
Interval 16.0 to 35.3
|
32.9 Percentage of participants
Interval 23.1 to 44.0
|
51.2 Percentage of participants
Interval 40.1 to 62.1
|
38.6 Percentage of participants
Interval 28.4 to 49.6
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
B/Yamagata
|
3.6 Percentage of participants
Interval 0.7 to 10.1
|
22.4 Percentage of participants
Interval 14.0 to 32.7
|
29.4 Percentage of participants
Interval 20.0 to 40.3
|
3.5 Percentage of participants
Interval 0.7 to 9.9
|
4.6 Percentage of participants
Interval 1.3 to 11.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before study vaccination on Day 1), 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
This measure is for percentage of participants achieving HAI titers \>=1:40 for each strain.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=84 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=85 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=86 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=88 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H1N1: Before Vaccination
|
55.4 Percentage of participants
Interval 44.1 to 66.3
|
41.2 Percentage of participants
Interval 30.6 to 52.4
|
47.1 Percentage of participants
Interval 36.1 to 58.2
|
48.8 Percentage of participants
Interval 37.9 to 59.9
|
45.5 Percentage of participants
Interval 34.8 to 56.4
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H1N1: 4 Weeks After Vaccination
|
95.2 Percentage of participants
Interval 88.3 to 98.7
|
89.4 Percentage of participants
Interval 80.8 to 95.0
|
90.6 Percentage of participants
Interval 82.3 to 95.8
|
91.9 Percentage of participants
Interval 83.9 to 96.7
|
93.2 Percentage of participants
Interval 85.7 to 97.5
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H3N2: Before Vaccination
|
67.5 Percentage of participants
Interval 56.3 to 77.4
|
65.9 Percentage of participants
Interval 54.8 to 75.8
|
62.7 Percentage of participants
Interval 51.3 to 73.0
|
64.0 Percentage of participants
Interval 52.9 to 74.0
|
61.4 Percentage of participants
Interval 50.4 to 71.6
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H3N2: 4 Weeks After Vaccination
|
97.6 Percentage of participants
Interval 91.7 to 99.7
|
98.8 Percentage of participants
Interval 93.5 to 100.0
|
85.5 Percentage of participants
Interval 76.1 to 92.3
|
96.5 Percentage of participants
Interval 90.1 to 99.3
|
98.9 Percentage of participants
Interval 93.8 to 100.0
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Victoria: Before Vaccination
|
27.4 Percentage of participants
Interval 18.2 to 38.2
|
21.2 Percentage of participants
Interval 13.1 to 31.4
|
31.8 Percentage of participants
Interval 22.1 to 42.8
|
33.7 Percentage of participants
Interval 23.9 to 44.7
|
35.2 Percentage of participants
Interval 25.3 to 46.1
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Victoria: 4 Weeks After Vaccination
|
66.7 Percentage of participants
Interval 55.5 to 76.6
|
52.9 Percentage of participants
Interval 41.8 to 63.9
|
67.1 Percentage of participants
Interval 56.0 to 76.9
|
77.9 Percentage of participants
Interval 67.7 to 86.1
|
69.3 Percentage of participants
Interval 58.6 to 78.7
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Yamagata: Before Vaccination
|
39.3 Percentage of participants
Interval 28.8 to 50.5
|
49.4 Percentage of participants
Interval 38.4 to 60.5
|
48.2 Percentage of participants
Interval 37.3 to 59.3
|
52.3 Percentage of participants
Interval 41.3 to 63.2
|
58.6 Percentage of participants
Interval 47.6 to 69.1
|
—
|
—
|
—
|
—
|
|
SSA: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Yamagata: 4 Weeks After Vaccination
|
50.0 Percentage of participants
Interval 38.9 to 61.1
|
78.8 Percentage of participants
Interval 68.6 to 86.9
|
74.1 Percentage of participants
Interval 63.5 to 83.0
|
61.6 Percentage of participants
Interval 50.5 to 71.9
|
63.6 Percentage of participants
Interval 52.7 to 73.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before study vaccination on Day 1), 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=83 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=78 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
B/Victoria: Before Vaccination
|
54.3 Titers
Interval 40.3 to 73.2
|
65.4 Titers
Interval 51.2 to 83.6
|
48.9 Titers
Interval 37.1 to 64.4
|
47.4 Titers
Interval 35.8 to 62.8
|
55.1 Titers
Interval 40.4 to 75.2
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
B/Victoria: 4 Weeks After Vaccination
|
102.6 Titers
Interval 80.4 to 130.9
|
159.9 Titers
Interval 127.1 to 201.3
|
94.1 Titers
Interval 74.5 to 118.8
|
109.0 Titers
Interval 85.6 to 138.8
|
115.7 Titers
Interval 89.3 to 149.9
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
B/Yamagata: Before Vaccination
|
48.6 Titers
Interval 40.4 to 58.5
|
44.7 Titers
Interval 37.3 to 53.5
|
46.1 Titers
Interval 38.6 to 55.1
|
46.3 Titers
Interval 39.1 to 54.8
|
47.9 Titers
Interval 39.7 to 57.7
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
B/Yamagata: 4 Weeks After Vaccination
|
72.6 Titers
Interval 61.2 to 86.1
|
74.3 Titers
Interval 61.9 to 89.0
|
71.2 Titers
Interval 60.0 to 84.6
|
52.1 Titers
Interval 44.2 to 61.4
|
61.9 Titers
Interval 50.8 to 75.4
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
A/H1N1: Before Vaccination
|
22.3 Titers
Interval 16.7 to 29.8
|
20.1 Titers
Interval 15.0 to 27.1
|
15.6 Titers
Interval 12.1 to 20.0
|
23.2 Titers
Interval 17.9 to 30.1
|
21.3 Titers
Interval 16.2 to 28.1
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
A/H1N1: 4 Weeks After Vaccination
|
94.3 Titers
Interval 70.7 to 125.8
|
47.2 Titers
Interval 33.9 to 65.6
|
58.3 Titers
Interval 43.0 to 79.1
|
74.2 Titers
Interval 55.6 to 99.0
|
131.2 Titers
Interval 93.8 to 183.6
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
A/H3N2: Before Vaccination
|
69.7 Titers
Interval 50.2 to 96.8
|
82.9 Titers
Interval 63.0 to 109.1
|
47.4 Titers
Interval 36.1 to 62.3
|
52.6 Titers
Interval 40.7 to 68.1
|
64.3 Titers
Interval 48.2 to 85.9
|
—
|
—
|
—
|
—
|
|
SSB: GMTs of Strain-Specific HAI Titers at Baseline and 4 Weeks After Vaccination
A/H3N2: 4 Weeks After Vaccination
|
284.7 Titers
Interval 205.6 to 394.3
|
183.2 Titers
Interval 134.5 to 249.5
|
144.2 Titers
Interval 106.8 to 194.7
|
216.6 Titers
Interval 163.1 to 287.5
|
364.0 Titers
Interval 269.6 to 491.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From before study vaccination on Day 1 up to 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=83 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=78 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
A/H1N1
|
3.5 Fold Rise
Interval 2.8 to 4.5
|
2.0 Fold Rise
Interval 1.6 to 2.5
|
2.9 Fold Rise
Interval 2.3 to 3.8
|
2.8 Fold Rise
Interval 2.3 to 3.4
|
5.0 Fold Rise
Interval 3.9 to 6.6
|
—
|
—
|
—
|
—
|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
A/H3N2
|
3.9 Fold Rise
Interval 3.0 to 5.0
|
2.2 Fold Rise
Interval 1.6 to 2.9
|
2.9 Fold Rise
Interval 2.3 to 3.7
|
4.0 Fold Rise
Interval 3.2 to 5.1
|
5.6 Fold Rise
Interval 4.2 to 7.4
|
—
|
—
|
—
|
—
|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
B/Victoria
|
1.7 Fold Rise
Interval 1.5 to 2.0
|
2.3 Fold Rise
Interval 1.8 to 2.8
|
1.8 Fold Rise
Interval 1.5 to 2.0
|
2.1 Fold Rise
Interval 1.8 to 2.5
|
1.9 Fold Rise
Interval 1.6 to 2.3
|
—
|
—
|
—
|
—
|
|
SSB: GMFRs of Strain-Specific HAI Titers From Before Vaccination to 4 Weeks After Vaccination
B/Yamagata
|
1.5 Fold Rise
Interval 1.3 to 1.6
|
1.6 Fold Rise
Interval 1.4 to 1.9
|
1.5 Fold Rise
Interval 1.3 to 1.7
|
1.1 Fold Rise
Interval 1.0 to 1.2
|
1.3 Fold Rise
Interval 1.2 to 1.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=83 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=78 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
A/H1N1
|
45.8 Percentage of participants
Interval 34.8 to 57.1
|
29.1 Percentage of participants
Interval 19.8 to 39.9
|
36.0 Percentage of participants
Interval 26.1 to 46.8
|
36.5 Percentage of participants
Interval 26.3 to 47.6
|
58.7 Percentage of participants
Interval 46.7 to 69.9
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
A/H3N2
|
49.4 Percentage of participants
Interval 38.2 to 60.6
|
28.7 Percentage of participants
Interval 19.5 to 39.4
|
35.6 Percentage of participants
Interval 25.7 to 46.3
|
51.7 Percentage of participants
Interval 40.8 to 62.6
|
60.3 Percentage of participants
Interval 48.5 to 71.2
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
B/Victoria
|
9.6 Percentage of participants
Interval 4.3 to 18.1
|
25.3 Percentage of participants
Interval 16.6 to 35.7
|
14.4 Percentage of participants
Interval 7.9 to 23.4
|
19.5 Percentage of participants
Interval 11.8 to 29.4
|
24.4 Percentage of participants
Interval 15.3 to 35.4
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination
B/Yamagata
|
4.9 Percentage of participants
Interval 1.3 to 12.0
|
14.0 Percentage of participants
Interval 7.4 to 23.1
|
5.6 Percentage of participants
Interval 1.8 to 12.5
|
1.2 Percentage of participants
Interval 0.0 to 6.3
|
2.6 Percentage of participants
Interval 0.3 to 9.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (before study vaccination on Day 1), 4 weeks after study vaccinationPopulation: Evaluable immunogenicity population. Here, Number Analyzed=number of participants evaluable for the specified rows.
This measure is for percentage of participants achieving HAI titers \>=1:40 for each strain.
Outcome measures
| Measure |
SSB: Influenza ModRNA Vaccine 5B
n=83 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=90 Participants
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=87 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=78 Participants
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H1N1: Before Vaccination
|
38.6 Percentage of participants
Interval 28.1 to 49.9
|
37.9 Percentage of participants
Interval 27.7 to 49.0
|
31.5 Percentage of participants
Interval 22.0 to 42.2
|
43.0 Percentage of participants
Interval 32.4 to 54.2
|
40.0 Percentage of participants
Interval 28.9 to 52.0
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H1N1: 4 Weeks After Vaccination
|
78.3 Percentage of participants
Interval 67.9 to 86.6
|
62.8 Percentage of participants
Interval 51.7 to 73.0
|
65.2 Percentage of participants
Interval 54.3 to 75.0
|
76.7 Percentage of participants
Interval 66.4 to 85.2
|
79.5 Percentage of participants
Interval 68.8 to 87.8
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H3N2: Before Vaccination
|
67.5 Percentage of participants
Interval 56.3 to 77.4
|
80.5 Percentage of participants
Interval 70.6 to 88.2
|
58.9 Percentage of participants
Interval 48.0 to 69.2
|
62.1 Percentage of participants
Interval 51.0 to 72.3
|
70.5 Percentage of participants
Interval 59.1 to 80.3
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
A/H3N2: 4 Weeks After Vaccination
|
94.0 Percentage of participants
Interval 86.5 to 98.0
|
90.8 Percentage of participants
Interval 82.7 to 95.9
|
87.8 Percentage of participants
Interval 79.2 to 93.7
|
93.1 Percentage of participants
Interval 85.6 to 97.4
|
94.9 Percentage of participants
Interval 87.4 to 98.6
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Victoria: Before Vaccination
|
68.7 Percentage of participants
Interval 57.6 to 78.4
|
80.5 Percentage of participants
Interval 70.6 to 88.2
|
68.9 Percentage of participants
Interval 58.3 to 78.2
|
58.6 Percentage of participants
Interval 47.6 to 69.1
|
67.9 Percentage of participants
Interval 56.4 to 78.1
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Victoria: 4 Weeks After Vaccination
|
84.3 Percentage of participants
Interval 74.7 to 91.4
|
93.1 Percentage of participants
Interval 85.6 to 97.4
|
86.7 Percentage of participants
Interval 77.9 to 92.9
|
85.1 Percentage of participants
Interval 75.8 to 91.8
|
88.5 Percentage of participants
Interval 79.2 to 94.6
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Yamagata: Before Vaccination
|
73.2 Percentage of participants
Interval 62.2 to 82.4
|
71.3 Percentage of participants
Interval 60.6 to 80.5
|
68.9 Percentage of participants
Interval 58.3 to 78.2
|
69.0 Percentage of participants
Interval 58.1 to 78.5
|
64.9 Percentage of participants
Interval 53.2 to 75.5
|
—
|
—
|
—
|
—
|
|
SSB: Percentage of Participants With HAI Titers >=1:40 For Each Strain at Baseline and 4 Weeks After Vaccination
B/Yamagata: 4 Weeks After Vaccination
|
86.6 Percentage of participants
Interval 77.3 to 93.1
|
87.2 Percentage of participants
Interval 78.3 to 93.4
|
82.2 Percentage of participants
Interval 72.7 to 89.5
|
76.7 Percentage of participants
Interval 66.4 to 85.2
|
81.8 Percentage of participants
Interval 71.4 to 89.7
|
—
|
—
|
—
|
—
|
Adverse Events
SSA: Influenza ModRNA Vaccine 2A
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
SSA: Influenza ModRNA Vaccine 3A
Serious events: 0 serious events
Other events: 84 other events
Deaths: 0 deaths
SSA: Influenza ModRNA Vaccine 4A
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
SSA: Influenza ModRNA Vaccine 5A
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
SSA: QIV 1
Serious events: 0 serious events
Other events: 63 other events
Deaths: 0 deaths
SSB: Influenza ModRNA Vaccine 3B
Serious events: 0 serious events
Other events: 76 other events
Deaths: 0 deaths
SSB: Influenza ModRNA Vaccine 4B
Serious events: 4 serious events
Other events: 67 other events
Deaths: 0 deaths
SSB: Influenza ModRNA Vaccine 5B
Serious events: 4 serious events
Other events: 68 other events
Deaths: 0 deaths
SSB: QIV 2
Serious events: 3 serious events
Other events: 47 other events
Deaths: 0 deaths
SSB: QIV 3
Serious events: 2 serious events
Other events: 50 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 3C
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 4C
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 5C
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 6C
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 7C
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 8C
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
SSC: Influenza ModRNA Vaccine 9C
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
SSC: QIV 2
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
SSC: QIV 3
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SSA: Influenza ModRNA Vaccine 2A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 3A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 4A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 5A
n=97 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
|
SSA: QIV 1
n=94 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 3B
n=90 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 4B
n=87 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 5B
n=90 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 5C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 6C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 7C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Infections and infestations
Arthritis bacterial
|
1.0%
1/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.2%
1/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.0%
1/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
1.0%
1/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
Other adverse events
| Measure |
SSA: Influenza ModRNA Vaccine 2A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 1 (preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 3A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 4A
n=96 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSA: Influenza ModRNA Vaccine 5A
n=97 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 1 intramuscularly on Day 1.
|
SSA: QIV 1
n=94 participants at risk
Participants aged 18 to 64 years were randomized to receive a single dose of licensed standard-dose QIV (QIV 1) at licensed dose intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 3B
n=90 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 2, formulation 2 (not preformulated) intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 4B
n=87 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: Influenza ModRNA Vaccine 5B
n=90 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSB: QIV 2
n=89 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSB: QIV 3
n=94 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 3C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 4C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 5C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza quadrivalent modRNA vaccine at dose level 5 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 6C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 5, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 7C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 4, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 8C
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 6, formulation 3 intramuscularly on Day 1.
|
SSC: Influenza ModRNA Vaccine 9C
n=31 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of influenza trivalent modRNA vaccine, at dose level 7, formulation 3 intramuscularly on Day 1.
|
SSC: QIV 2
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed high-dose QIV (QIV 2) at licensed dose intramuscularly on Day 1.
|
SSC: QIV 3
n=30 participants at risk
Participants aged \>=65 years were randomized to receive a single dose of licensed adjuvanted QIV (QIV 3) at licensed dose intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
16.7%
16/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.5%
11/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.2%
5/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
18.6%
18/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.6%
9/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
15.6%
14/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.2%
8/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.6%
5/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.2%
10/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.6%
9/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.7%
3/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Chills (CHILLS)
|
27.1%
26/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
25.0%
24/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
29.2%
28/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
26.8%
26/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
7.4%
7/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
3/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
21.8%
19/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
18/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
2.1%
2/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
23.3%
7/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
13.3%
4/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
36.7%
11/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
19.4%
6/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
56.2%
54/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
57.3%
55/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
53.1%
51/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
66.0%
64/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
41.5%
39/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
39/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
46.0%
40/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
45.6%
41/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
22.5%
20/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
24.5%
23/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
13/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
13/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
40.0%
12/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
33.3%
10/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
26.7%
8/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
56.7%
17/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
35.5%
11/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
23.3%
7/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
26.7%
8/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site erythema (REDNESS)
|
4.2%
4/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
2.1%
2/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.2%
6/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
4.1%
4/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
2.1%
2/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.1%
10/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.7%
5/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
8.9%
8/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
4.5%
4/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.3%
5/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
19.4%
6/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site pain (PAIN)
|
82.3%
79/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
82.3%
79/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
79.2%
76/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
72.2%
70/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
42.6%
40/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
64.4%
58/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
62.1%
54/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
64.4%
58/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
40.4%
36/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
39.4%
37/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
73.3%
22/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
13/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
73.3%
22/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
70.0%
21/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
73.3%
22/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
86.7%
26/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
61.3%
19/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
13/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
50.0%
15/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
11.5%
11/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
8.3%
8/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.4%
10/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.2%
6/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.6%
5/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.7%
5/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
5.6%
5/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.7%
3/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
General disorders
Injection site swelling (SWELLING)
|
10.4%
10/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.1%
3/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
8.3%
8/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.2%
6/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
1.1%
1/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
7.8%
7/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
4.6%
4/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.1%
10/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.0%
8/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
9.6%
9/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
13.3%
4/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
13.3%
4/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.1%
5/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
27.1%
26/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
24.0%
23/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
17.7%
17/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
25.8%
25/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
8.5%
8/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
12.2%
11/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.1%
14/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
15/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
7.9%
7/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.2%
3/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.7%
2/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
23.3%
7/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
6.5%
2/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
3.3%
1/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLE PAIN)
|
38.5%
37/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
44.8%
43/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
33.3%
32/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
32.0%
31/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
12.8%
12/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
21.1%
19/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
19.5%
17/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
23.3%
21/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.2%
10/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
4.3%
4/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
13.3%
4/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
36.7%
11/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
12.9%
4/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
0.00%
0/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
10.0%
3/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
50.0%
48/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
47.9%
46/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
50.0%
48/96 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
51.5%
50/97 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.2%
19/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
27.8%
25/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.7%
18/87 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
28.9%
26/90 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
12.4%
11/89 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
11.7%
11/94 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
26.7%
8/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
43.3%
13/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
30.0%
9/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
30.0%
9/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
46.7%
14/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
45.2%
14/31 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
20.0%
6/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
16.7%
5/30 • Local reactions and systemic events were assessed from study vaccination on Day 1 to Day 7 after study vaccination; MAEs, NDCMCs, SAEs and all-cause mortality: from study vaccination on Day 1 up to 6 months after study vaccination; All Other AEs: from study vaccination on Day 1 up to 4 weeks after study vaccination
Same event may appear as both other AE (non-SAE) and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and other AE (non-SAE). Safety population included all participants who received the study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER