Trial Outcomes & Findings for A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People (NCT NCT06683352)
NCT ID: NCT06683352
Last Updated: 2026-08-19
Results Overview
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1353 participants
Primary outcome timeframe
From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]
Results posted on
2026-08-19
Participant Flow
There were 2 cohorts in the study: Cohort 1 enrolled participants 18 to 64 years of age and Cohort 2 enrolled participants \>=65 years of age.
Dose strengths for vaccines have not been disclosed in the record, as per Sponsor's decision to maintain company confidentiality; the dose strengths have been denoted as low dose, medium dose and high dose.
Participant milestones
| Measure |
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose coronavirus disease 2019 (COVID-19) vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
Participants 18 to 64 years of age were randomized to be administered with licensed influenza vaccine 1 and licensed COVID-19 30 micrograms (mcg) vaccine intramuscularly on Day 1.
|
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
Participants \>=65 years of age were randomized to be administered with licensed influenza vaccine 2 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
51
|
50
|
50
|
50
|
50
|
50
|
50
|
51
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
50
|
|
Overall Study
Vaccinated
|
51
|
50
|
49
|
50
|
50
|
50
|
50
|
50
|
49
|
49
|
51
|
50
|
50
|
50
|
50
|
50
|
49
|
50
|
50
|
50
|
50
|
50
|
49
|
50
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
49
|
49
|
47
|
48
|
48
|
47
|
48
|
48
|
43
|
50
|
48
|
50
|
45
|
48
|
50
|
48
|
46
|
48
|
49
|
49
|
49
|
47
|
48
|
48
|
49
|
48
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
3
|
2
|
2
|
3
|
2
|
2
|
7
|
1
|
2
|
0
|
5
|
2
|
0
|
2
|
5
|
2
|
1
|
1
|
1
|
3
|
2
|
2
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose coronavirus disease 2019 (COVID-19) vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
Participants 18 to 64 years of age were randomized to be administered with licensed influenza vaccine 1 and licensed COVID-19 30 micrograms (mcg) vaccine intramuscularly on Day 1.
|
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age were randomized to be administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
Participants \>=65 years of age were randomized to be administered with licensed influenza vaccine 2 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Participants \>=65 years of age were randomized to be administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
2
|
1
|
3
|
2
|
0
|
5
|
0
|
2
|
0
|
4
|
1
|
0
|
1
|
3
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other: Unspecified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Randomized but not vaccinated
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
Baseline characteristics by cohort
| Measure |
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1+ Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants \>=65 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
n=50 Participants
Participants \>=65 years of age who were administered with licensed influenza vaccine 2 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Total
n=1347 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-64 years
|
51 Participants
n=298 Participants
|
50 Participants
n=102 Participants
|
49 Participants
n=400 Participants
|
50 Participants
n=30 Participants
|
50 Participants
n=1389 Participants
|
50 Participants
n=44 Participants
|
50 Participants
n=44 Participants
|
50 Participants
n=97 Participants
|
49 Participants
n=23 Participants
|
49 Participants
n=23 Participants
|
51 Participants
n=748 Participants
|
50 Participants
n=122 Participants
|
50 Participants
n=30 Participants
|
50 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=33 Participants
|
699 Participants
n=28 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
50 Participants
n=30 Participants
|
50 Participants
n=23 Participants
|
49 Participants
n=35 Participants
|
50 Participants
n=34 Participants
|
50 Participants
n=34 Participants
|
50 Participants
n=27 Participants
|
50 Participants
n=113 Participants
|
50 Participants
n=103 Participants
|
49 Participants
n=27 Participants
|
50 Participants
n=22 Participants
|
50 Participants
n=30 Participants
|
50 Participants
n=24 Participants
|
50 Participants
n=33 Participants
|
648 Participants
n=28 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=298 Participants
|
25 Participants
n=102 Participants
|
25 Participants
n=400 Participants
|
27 Participants
n=30 Participants
|
29 Participants
n=1389 Participants
|
29 Participants
n=44 Participants
|
27 Participants
n=44 Participants
|
29 Participants
n=97 Participants
|
29 Participants
n=23 Participants
|
23 Participants
n=23 Participants
|
34 Participants
n=748 Participants
|
25 Participants
n=122 Participants
|
28 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
31 Participants
n=23 Participants
|
31 Participants
n=35 Participants
|
28 Participants
n=34 Participants
|
28 Participants
n=34 Participants
|
21 Participants
n=27 Participants
|
31 Participants
n=113 Participants
|
31 Participants
n=103 Participants
|
23 Participants
n=27 Participants
|
16 Participants
n=22 Participants
|
24 Participants
n=30 Participants
|
32 Participants
n=24 Participants
|
23 Participants
n=33 Participants
|
731 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=298 Participants
|
25 Participants
n=102 Participants
|
24 Participants
n=400 Participants
|
23 Participants
n=30 Participants
|
21 Participants
n=1389 Participants
|
21 Participants
n=44 Participants
|
23 Participants
n=44 Participants
|
21 Participants
n=97 Participants
|
20 Participants
n=23 Participants
|
26 Participants
n=23 Participants
|
17 Participants
n=748 Participants
|
25 Participants
n=122 Participants
|
22 Participants
n=30 Participants
|
19 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
19 Participants
n=23 Participants
|
18 Participants
n=35 Participants
|
22 Participants
n=34 Participants
|
22 Participants
n=34 Participants
|
29 Participants
n=27 Participants
|
19 Participants
n=113 Participants
|
19 Participants
n=103 Participants
|
26 Participants
n=27 Participants
|
34 Participants
n=22 Participants
|
26 Participants
n=30 Participants
|
18 Participants
n=24 Participants
|
27 Participants
n=33 Participants
|
616 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=298 Participants
|
16 Participants
n=102 Participants
|
14 Participants
n=400 Participants
|
10 Participants
n=30 Participants
|
17 Participants
n=1389 Participants
|
12 Participants
n=44 Participants
|
18 Participants
n=44 Participants
|
18 Participants
n=97 Participants
|
14 Participants
n=23 Participants
|
13 Participants
n=23 Participants
|
16 Participants
n=748 Participants
|
11 Participants
n=122 Participants
|
20 Participants
n=30 Participants
|
17 Participants
n=31 Participants
|
20 Participants
n=30 Participants
|
20 Participants
n=23 Participants
|
19 Participants
n=35 Participants
|
17 Participants
n=34 Participants
|
16 Participants
n=34 Participants
|
18 Participants
n=27 Participants
|
19 Participants
n=113 Participants
|
18 Participants
n=103 Participants
|
20 Participants
n=27 Participants
|
22 Participants
n=22 Participants
|
26 Participants
n=30 Participants
|
24 Participants
n=24 Participants
|
24 Participants
n=33 Participants
|
471 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=298 Participants
|
34 Participants
n=102 Participants
|
35 Participants
n=400 Participants
|
38 Participants
n=30 Participants
|
33 Participants
n=1389 Participants
|
37 Participants
n=44 Participants
|
31 Participants
n=44 Participants
|
30 Participants
n=97 Participants
|
35 Participants
n=23 Participants
|
36 Participants
n=23 Participants
|
35 Participants
n=748 Participants
|
39 Participants
n=122 Participants
|
29 Participants
n=30 Participants
|
33 Participants
n=31 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=23 Participants
|
30 Participants
n=35 Participants
|
32 Participants
n=34 Participants
|
34 Participants
n=34 Participants
|
32 Participants
n=27 Participants
|
31 Participants
n=113 Participants
|
31 Participants
n=103 Participants
|
29 Participants
n=27 Participants
|
28 Participants
n=22 Participants
|
24 Participants
n=30 Participants
|
25 Participants
n=24 Participants
|
25 Participants
n=33 Participants
|
864 Participants
n=28 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=122 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=33 Participants
|
12 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=748 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=298 Participants
|
4 Participants
n=102 Participants
|
5 Participants
n=400 Participants
|
8 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
4 Participants
n=44 Participants
|
4 Participants
n=44 Participants
|
4 Participants
n=97 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
6 Participants
n=748 Participants
|
4 Participants
n=122 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=23 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=113 Participants
|
3 Participants
n=103 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=22 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=33 Participants
|
72 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
0 Participants
n=103 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=33 Participants
|
3 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=298 Participants
|
15 Participants
n=102 Participants
|
12 Participants
n=400 Participants
|
11 Participants
n=30 Participants
|
19 Participants
n=1389 Participants
|
15 Participants
n=44 Participants
|
12 Participants
n=44 Participants
|
9 Participants
n=97 Participants
|
9 Participants
n=23 Participants
|
13 Participants
n=23 Participants
|
17 Participants
n=748 Participants
|
14 Participants
n=122 Participants
|
14 Participants
n=30 Participants
|
9 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
13 Participants
n=23 Participants
|
11 Participants
n=35 Participants
|
16 Participants
n=34 Participants
|
6 Participants
n=34 Participants
|
14 Participants
n=27 Participants
|
9 Participants
n=113 Participants
|
10 Participants
n=103 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=22 Participants
|
7 Participants
n=30 Participants
|
13 Participants
n=24 Participants
|
10 Participants
n=33 Participants
|
321 Participants
n=28 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=298 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=1389 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=748 Participants
|
4 Participants
n=122 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
2 Participants
n=34 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=33 Participants
|
18 Participants
n=28 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=298 Participants
|
30 Participants
n=102 Participants
|
32 Participants
n=400 Participants
|
30 Participants
n=30 Participants
|
29 Participants
n=1389 Participants
|
29 Participants
n=44 Participants
|
33 Participants
n=44 Participants
|
35 Participants
n=97 Participants
|
37 Participants
n=23 Participants
|
33 Participants
n=23 Participants
|
27 Participants
n=748 Participants
|
28 Participants
n=122 Participants
|
32 Participants
n=30 Participants
|
38 Participants
n=31 Participants
|
38 Participants
n=30 Participants
|
34 Participants
n=23 Participants
|
37 Participants
n=35 Participants
|
34 Participants
n=34 Participants
|
40 Participants
n=34 Participants
|
35 Participants
n=27 Participants
|
39 Participants
n=113 Participants
|
35 Participants
n=103 Participants
|
37 Participants
n=27 Participants
|
36 Participants
n=22 Participants
|
42 Participants
n=30 Participants
|
34 Participants
n=24 Participants
|
39 Participants
n=33 Participants
|
924 Participants
n=28 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=298 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=400 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=1389 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=97 Participants
|
1 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=748 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=113 Participants
|
1 Participants
n=103 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=33 Participants
|
6 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
Local reactions included redness, swelling, and pain at the injection site, were recorded in the electronic dairy (e-diary) or case report form (CRF) after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=48 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
|
70.0 Percentage of participants
Interval 55.4 to 82.1
|
50.0 Percentage of participants
Interval 35.5 to 64.5
|
61.2 Percentage of participants
Interval 46.2 to 74.8
|
65.3 Percentage of participants
Interval 50.4 to 78.3
|
80.0 Percentage of participants
Interval 66.3 to 90.0
|
42.0 Percentage of participants
Interval 28.2 to 56.8
|
74.0 Percentage of participants
Interval 59.7 to 85.4
|
72.0 Percentage of participants
Interval 57.5 to 83.8
|
79.6 Percentage of participants
Interval 65.7 to 89.8
|
89.6 Percentage of participants
Interval 77.3 to 96.5
|
78.4 Percentage of participants
Interval 64.7 to 88.7
|
86.0 Percentage of participants
Interval 73.3 to 94.2
|
69.4 Percentage of participants
Interval 54.6 to 81.7
|
90.0 Percentage of participants
Interval 78.2 to 96.7
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
Local reactions included redness, swelling, and pain at the injection site, were recorded in the e-diary or CRF after vaccination. Local reactions were graded per the 'Local Reaction Grading Scale' per protocol. Percentage of participants with at least 1 local reaction of grade 1 and above were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=49 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=48 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Any Local Reactions for up to 7 Days Following Vaccination
|
58.0 Percentage of participants
Interval 43.2 to 71.8
|
30.0 Percentage of participants
Interval 17.9 to 44.6
|
42.0 Percentage of participants
Interval 28.2 to 56.8
|
42.9 Percentage of participants
Interval 28.8 to 57.8
|
64.0 Percentage of participants
Interval 49.2 to 77.1
|
36.7 Percentage of participants
Interval 23.4 to 51.7
|
66.0 Percentage of participants
Interval 51.2 to 78.8
|
63.3 Percentage of participants
Interval 48.3 to 76.6
|
66.7 Percentage of participants
Interval 51.6 to 79.6
|
60.0 Percentage of participants
Interval 45.2 to 73.6
|
68.0 Percentage of participants
Interval 53.3 to 80.5
|
60.0 Percentage of participants
Interval 45.2 to 73.6
|
67.3 Percentage of participants
Interval 52.5 to 80.1
|
—
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=48 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
|
68.0 Percentage of participants
Interval 53.3 to 80.5
|
64.0 Percentage of participants
Interval 49.2 to 77.1
|
57.1 Percentage of participants
Interval 42.2 to 71.2
|
49.0 Percentage of participants
Interval 34.4 to 63.7
|
72.0 Percentage of participants
Interval 57.5 to 83.8
|
44.0 Percentage of participants
Interval 30.0 to 58.7
|
68.0 Percentage of participants
Interval 53.3 to 80.5
|
68.0 Percentage of participants
Interval 53.3 to 80.5
|
77.6 Percentage of participants
Interval 63.4 to 88.2
|
70.8 Percentage of participants
Interval 55.9 to 83.0
|
70.6 Percentage of participants
Interval 56.2 to 82.5
|
78.0 Percentage of participants
Interval 64.0 to 88.5
|
73.5 Percentage of participants
Interval 58.9 to 85.1
|
76.0 Percentage of participants
Interval 61.8 to 86.9
|
PRIMARY outcome
Timeframe: From Day 1 through Day 7 after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention. Here "Overall Number of Participants Analyzed" signifies number of participants reporting at least 1 response in the e-diary or CRF after vaccination.
Systemic Events: fever, diarrhea, vomiting, headache, fatigue/tiredness, chills, new or worsened muscle pain, and new or worsened joint pain, were recorded in the e-diary or CRF after vaccination. Systemic events were graded per the 'Systemic Events Grading Scale' per protocol. Percentage of participants with at least 1 systemic event of grade 1 and above were reported in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=49 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=48 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants With Any Systemic Events for up to 7 Days Following Vaccination
|
36.0 Percentage of participants
Interval 22.9 to 50.8
|
34.0 Percentage of participants
Interval 21.2 to 48.8
|
38.0 Percentage of participants
Interval 24.7 to 52.8
|
40.8 Percentage of participants
Interval 27.0 to 55.8
|
62.0 Percentage of participants
Interval 47.2 to 75.3
|
40.8 Percentage of participants
Interval 27.0 to 55.8
|
62.0 Percentage of participants
Interval 47.2 to 75.3
|
49.0 Percentage of participants
Interval 34.4 to 63.7
|
56.3 Percentage of participants
Interval 41.2 to 70.5
|
46.0 Percentage of participants
Interval 31.8 to 60.7
|
56.0 Percentage of participants
Interval 41.3 to 70.0
|
46.0 Percentage of participants
Interval 31.8 to 60.7
|
57.1 Percentage of participants
Interval 42.2 to 71.2
|
—
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. Serious AE (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. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting Adverse Events (AEs) From Vaccination Through 1 Month After Vaccination
|
4.0 Percentage of participants
Interval 0.5 to 13.7
|
3.9 Percentage of participants
Interval 0.5 to 13.5
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
6.1 Percentage of participants
Interval 1.3 to 16.9
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
10.0 Percentage of participants
Interval 3.3 to 21.8
|
8.0 Percentage of participants
Interval 2.2 to 19.2
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
10.2 Percentage of participants
Interval 3.4 to 22.2
|
10.2 Percentage of participants
Interval 3.4 to 22.2
|
5.9 Percentage of participants
Interval 1.2 to 16.2
|
6.0 Percentage of participants
Interval 1.3 to 16.5
|
8.0 Percentage of participants
Interval 2.2 to 19.2
|
6.0 Percentage of participants
Interval 1.3 to 16.5
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 1 month after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention.
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious AEs. 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. Only AEs collected by non-systematic assessment (excluding local reactions and systematic events) were included in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting AEs From Vaccination Through 1 Month After Vaccination
|
4.0 Percentage of participants
Interval 0.5 to 13.7
|
8.0 Percentage of participants
Interval 2.2 to 19.2
|
12.0 Percentage of participants
Interval 4.5 to 24.3
|
12.2 Percentage of participants
Interval 4.6 to 24.8
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
6.0 Percentage of participants
Interval 1.3 to 16.5
|
6.0 Percentage of participants
Interval 1.3 to 16.5
|
8.0 Percentage of participants
Interval 2.2 to 19.2
|
4.1 Percentage of participants
Interval 0.5 to 14.0
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
4.0 Percentage of participants
Interval 0.5 to 13.7
|
12.0 Percentage of participants
Interval 4.5 to 24.3
|
8.0 Percentage of participants
Interval 2.2 to 19.2
|
—
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention.
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, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.0
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
0 Percentage of participants
Interval 0.0 to 7.3
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
2.0 Percentage of participants
Interval 0.1 to 10.9
|
0 Percentage of participants
Interval 0.0 to 7.3
|
0 Percentage of participants
Interval 0.0 to 7.0
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
PRIMARY outcome
Timeframe: From Vaccination on Day 1 through 6 Months after Vaccination [Vaccination on Day 1]Population: Safety analysis population included all participants who received any study intervention.
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, and any other pre-specified criteria in protocol of the study or other important medical event. Only SAEs collected by non-systematic assessment (excluding local reactions and systematic events \[if any\]) were included in this outcome measure.
Outcome measures
| Measure |
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 Participants
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 Participants
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 Participants
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cohort 2: Percentage of Participants Reporting SAEs From Vaccination Through 6 Months After Vaccination
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
6.1 Percentage of participants
Interval 1.3 to 16.9
|
4.0 Percentage of participants
Interval 0.5 to 13.7
|
0 Percentage of participants
Interval 0.0 to 7.1
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
0 Percentage of participants
Interval 0.0 to 7.1
|
2.0 Percentage of participants
Interval 0.1 to 10.9
|
2.0 Percentage of participants
Interval 0.1 to 10.6
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
0 Percentage of participants
Interval 0.0 to 7.1
|
—
|
Adverse Events
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Serious events: 1 serious events
Other events: 45 other events
Deaths: 0 deaths
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
Serious events: 2 serious events
Other events: 37 other events
Deaths: 1 deaths
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Serious events: 1 serious events
Other events: 38 other events
Deaths: 0 deaths
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
Serious events: 1 serious events
Other events: 35 other events
Deaths: 1 deaths
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
Serious events: 0 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=51 participants at risk
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 participants at risk
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants \>=65 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
n=50 participants at risk
Participants \>=65 years of age who were administered with licensed influenza vaccine 2 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Chest pain
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Sepsis
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
Other adverse events
| Measure |
Cohort 1, Arm A: Low Dose COVID-19 Vaccine + Placebo
n=51 participants at risk
Participants 18 to 64 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm B: Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm C: High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm D: Low Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm E: Licensed Influenza Vaccine 1 + Licensed COVID-19 Vaccine
n=50 participants at risk
Participants 18 to 64 years of age who were administered with licensed influenza vaccine 1 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 1, Arm F: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm G: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm H: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm I: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm J: High Dose Investigational Influenza Vaccine + Placebo
n=49 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm K: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine +Placebo
n=51 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm L: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm M: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 1, Arm N: High Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants 18 to 64 years of age who were administered with high dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm AA: Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm BB: Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm CC: High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants \>=65 years of age who were administered with high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm DD: Low Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm EE: Licensed Influenza Vaccine 2 + Licensed COVID-19 Vaccine
n=50 participants at risk
Participants \>=65 years of age who were administered with licensed influenza vaccine 2 and licensed COVID-19 30 mcg vaccine intramuscularly on Day 1.
|
Cohort 2, Arm FF: Medium Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm GG: Low Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm HH: Medium Dose Investigational Influenza Vaccine/Low Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/low dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm II: Low Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=49 participants at risk
Participants \>=65 years of age who were administered with low dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm JJ: High Dose Investigational Influenza Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm KK: Medium Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine+Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm LL: Medium Dose Investigational Influenza Vaccine/High Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with medium dose investigational influenza vaccine/high dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
Cohort 2, Arm MM: High Dose Investigational Influenza Vaccine/Medium Dose COVID-19 Vaccine + Placebo
n=50 participants at risk
Participants \>=65 years of age who were administered with high dose investigational influenza vaccine/medium dose COVID-19 vaccine and placebo intramuscularly on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Chills (CHILLS)
|
13.7%
7/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.0%
19/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
46.0%
23/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
32.0%
16/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.8%
19/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
46.9%
23/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
33.3%
17/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
48.0%
24/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.0%
19/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
48.0%
24/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.1%
2/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
16.0%
8/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.4%
9/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.0%
11/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Fatigue (FATIGUE)
|
47.1%
24/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
44.0%
22/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.8%
19/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
60.0%
30/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
56.0%
28/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
58.0%
29/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
54.0%
27/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
75.5%
37/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
59.2%
29/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
56.9%
29/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
72.0%
36/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
56.0%
28/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
66.0%
33/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
16.0%
8/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
44.0%
22/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.0%
13/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.0%
13/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.0%
19/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
42.9%
21/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
46.0%
23/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.0%
19/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Injection site erythema (REDNESS)
|
2.0%
1/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.1%
2/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.2%
6/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
7.8%
4/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.1%
2/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Injection site pain (PAIN)
|
49.0%
25/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
60.0%
30/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
65.3%
32/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
80.0%
40/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
40.0%
20/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
70.0%
35/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
72.0%
36/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
72.0%
36/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
79.6%
39/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
87.8%
43/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
78.4%
40/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
86.0%
43/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
68.0%
34/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
88.0%
44/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
30.0%
15/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
42.0%
21/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
40.8%
20/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
62.0%
31/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
32.0%
16/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
56.0%
28/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
66.0%
33/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
58.0%
29/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
61.2%
30/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
60.0%
30/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
66.0%
33/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
58.0%
29/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
66.0%
33/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Injection site swelling (SWELLING)
|
5.9%
3/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.2%
6/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.4%
11/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
7.8%
4/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.1%
3/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.2%
6/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
General disorders
Pyrexia (FEVER)
|
2.0%
1/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.4%
9/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.1%
3/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
11.8%
6/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
16.0%
8/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Gastrointestinal disorders
Diarrhoea (DIARRHEA)
|
11.8%
6/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.1%
3/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
16.0%
8/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
16.0%
8/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.2%
6/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
7.8%
4/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.1%
2/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
4.0%
2/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.1%
3/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
3.9%
2/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
2.0%
1/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
0.00%
0/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (JOINT PAIN)
|
7.8%
4/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.0%
13/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.0%
13/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.4%
10/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.4%
9/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
27.5%
14/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.0%
13/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.2%
5/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
10.0%
5/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.0%
4/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
6.0%
3/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
8.2%
4/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (MUSCLEPAIN)
|
19.6%
10/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.2%
6/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
30.0%
15/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
42.9%
21/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.5%
13/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
37.3%
19/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
32.0%
16/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
38.0%
19/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.3%
7/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
18.0%
9/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
12.0%
6/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.4%
10/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.0%
11/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
|
Nervous system disorders
Headache (HEADACHE)
|
43.1%
22/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
34.0%
17/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
26.5%
13/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
50.0%
25/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
40.0%
20/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
44.0%
22/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
42.0%
21/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
51.0%
25/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
42.9%
21/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
51.0%
26/51 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
56.0%
28/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
40.0%
20/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
50.0%
25/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
14.0%
7/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.0%
11/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.4%
11/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
34.0%
17/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
20.0%
10/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.5%
12/49 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
22.0%
11/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
24.0%
12/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
28.0%
14/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
36.0%
18/50 • Systematic assessment: Local reactions and systemic events were assessed from Vaccination on Day 1 to Day 7 after Vaccination; Non-systematic assessment: SAEs were assessed from Vaccination on Day 1 up to 6 months after Vaccination; other AEs were assessed from Vaccination on Day 1 up to 1 month after Vaccination; all-cause mortality: from Vaccination on Day 1 up to 6 months after Vaccination
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis population was evaluated for all the results reported below, hence "At Risk" included all participants who received any study intervention.
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Phone: +49 6131 90840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor (or its agents) 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